Marked precoated medical device and method of manufacturing same

ABSTRACT

A method of manufacturing a coated medical device, such as a medical guide wire, including at least applying a first colored coating to at least a first portion of an outer surface of a medical guide wire, securing a first end of the medical guide wire, and for each a designated quantity of turns, turn a second end of the medical guide wire upon a longitudinal axis of the medical guide wire. The method of manufacturing also includes securing the second end of the medical guide wire, blocking at least a first portion of the coated surface of the medical guide wire, applying a second contrasting colored coating to at least a second, unblocked portion of the outer surface of the medical guide wire and releasing the first end and the second end of the medical guide wire to display at least one spiral marking formed along a length of the medical guide wire.

PRIORITY CLAIM

This application is a continuation of, claims priority to and thebenefit of U.S. patent application Ser. No. 12/367,929, filed on Feb. 9,2009, which is a continuation-in-part of, claims the benefit of andpriority to U.S. patent application Ser. No. 12/171,847, filed on Jul.11, 2008, which is a continuation-in-part of, claims the benefit of andpriority to U.S. patent application Ser. No. 11/962,326, filed on Dec.21, 2007, the entire contents of each are incorporated by referenceherein.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is related to the following commonly-owned co-pendingpatent applications: “MARKED PRECOATED MEDICAL DEVICE AND METHOD OFMANUFACTURING SAME,” Ser. No. 13/535,009, Attorney Docket No.025099-0046, and “MARKED PRECOATED STRINGS AND METHOD OF MANUFACTURINGSAME,” Ser. No. 13/040,829, Attorney Docket No, 025099-0041.

BACKGROUND

Medical devices such as wires, guide wires, probes, mandrels, needles,cannulas, and other medical devices are commonly inserted into humans oranimals for therapeutic and diagnostic medical procedures. Often,surgeons or other medical professionals must be able to determine thespecific distance that a medical device is inserted into a body. Theaccurate placement of the medical device is often critical to theprocedure. If a medical device is inserted too far into a patient, itcould tear, puncture, or otherwise cause damage to internal bodilytissues, vessels, and other organs, which could be harmful orpotentially fatal to the patient. Alternatively, if not inserted farenough, the procedure may not be successfully performed. Accordingly,certain medical devices are marked with visual indicia at measuredintervals along the length of the device to indicate the length of themedical device inserted into a patient.

Additionally, many medical devices are coated with one or more lowfriction materials such as polytetrafluoroethylene (PTFE). Low friction,low surface energy coatings reduce the amount of friction between themedical device and bodily tissues, catheters, or other surfaces. Withoutlow friction coatings, certain medical devices are more likely to“stick” to tissues, catheters, or other surfaces during insertion orextraction. If a medical device sticks to other surfaces as it isinserted into a body, a surgeon or other medical professional must applya greater insertion force to the medical device to reinitiate movement.Once movement is reinitiated, the opposing force immediately decreasesso that the medical device is caused to quickly accelerate into thebody. Such extreme movements increase the risk of scraping, rubbing,tearing, puncturing, or otherwise damaging a patient's internal tissuesdue to misplacing the end of the device in the patient. Low frictioncoatings are less likely to stick to other surfaces and therefore givesurgeons or other medical professionals more control or modulate overthe insertion speed and depth, which reduces the risk of damage to thepatient, thus reducing the “slip-stick” phenomena. Additionally, lowfriction coatings generally have smooth surfaces that will not scrape,irritate, or snag tissues, vessels or arteries. However, there are verylimited methods for marking such devices with low friction coatings.

One known method of marking low friction coated medical devices is togrind, ablate or acid remove the low friction coating to expose thesurface of the medical device so that the contrast between the color ofthe low friction coating and the base metal or surface of the medicaldevice can serve as visual indicia. Ablation is typically achieved byusing corrosive chemicals or laser beams, or grinding or grit blastingto selectively remove the coating from the medical device. Such ablationor grinding methods remove the entire coating from the surface of thedevice, which creates grooves or valleys in the surface of thelow-friction or other coating. The shoulders of these grooves or valleyscan have sharp edges, particularly when laser beams, grinding, or othersimilar techniques are used to remove the coating. The resulting sharpedges can scrape bodily tissues, snag vessels or arteries of thepatient, or otherwise cause damage and/or trauma to the patient. Wheninserting medical devices into delicate areas such as the brain andheart, damage caused by the sharp shoulders of the grooves or valleyscan be harmful and potentially fatal for the patient. Even if theshoulders are shaped to reduce or eliminate sharp edges, this method ofmarking low friction coated medical devices still removes the benefitsof the low friction coating and exposes the raw, unprotected surface ofthe medical device, particularly when a wire device changes directionsor goes around a turn in a vessel, vein or artery. As described above,the exposed surface of the medical device (and especially any largeexposed surfaces of the medical device) is more likely to stick tobodily tissues and other surfaces, potentially harming the patient.Additionally, this method of marking low friction coated medical devicescreates different diameters along the length of the medical device whichcan also increase the required insertion force and decrease the controla surgeon or other medical professional can exercise over the speed anddepth of an insertion. Therefore, the above method of marking lowfriction coated medical devices adversely affects the function of thecoated medical device and can increase the risk of injury to a patientby creating a high friction area.

Another known method of marking low friction coated medical devices isto print ink or otherwise deposit ink or paint on the surface of thecoating. However, low friction coatings resist bonding with inks, andinks printed on low friction coatings may peel off and be left insidethe patient's body, which may harm the patient. Ink may also rub or peeloff before or during use of the medical device, thus destroying theusefulness of the markings, and increasing the risk that the medicaldevice will be inserted either too deep, or not deep enough (and harmthe patient and/or render the medical procedure ineffective).Furthermore, many medical devices have small diameters such that eventhin layers of ink can significantly increase the diameter of thedevice, which, as previously described, is undesirable.

Marking low friction coated medical guide wires poses additionalproblems. Medical guide wires are generally shaped like coiled springs,having an elongated strand of medical wire helically wound such thatadjacent turns of the wire are in contact with each other. Known methodsof marking low friction coated medical guide wires, such as grinding orablating the coating to expose the surface of the medical guide wireeach have the disadvantages of either increasing or decreasing thediameter of the medical guide wire and/or removing the low frictioncoating, which is undesirable. Removal of the coating by mechanicalprocesses such as by grinding or using abrasives could possibly weakenthe thin wire that forms the coils of the medical guide wire. Laserablation does not harm the wire, however it removes the low frictioncoating which is undesirable. Additionally, despite repeated rinsing,material removed from the coating can get caught between the turns oradjacent segments of the medical wire and can be deposited in apatient's body during a medical procedure, which could be potentiallyharmful or even fatal for the patient. Furthermore, marking the coatedmedical guide wire with paint is not effective because paint will easilycrack and delaminate between adjacent turns of the medical guide wireand the paint could be deposited in a patient's body, which could alsobe harmful and potentially fatal for the patient.

One known method of forming a low-friction coating on a medical deviceincludes applying an aqueous PTFE solution to the surface of a medicaldevice. The solution includes particles of a low friction material suchas PTFE, an acid such as chromic acid, a pigment, wetting agents, otheringredients, and distilled water. The solution is cured at a hightemperature such as 750° F. (399° C.) to cure the coating andpermanently adhere the coating to the substrate. The pigments used inthis method are generally stable at temperatures exceeding the curetemperature so that they do not shift color during the curing process.Although the pigments used in this method generally will shift color attemperatures above the cure temperature, when heated to suchtemperatures the low friction characteristic of the PTFE coatingpermanently degrades and the bonds between the low friction coating andthe medical device weaken, which destroys the coating adhesion,properties and utility of the low friction coating.

Accordingly, a need exists for improved markings on medical devices, andspecifically medical wires or tube type devices with low frictioncoatings. Such a need exists for medical devices with markings that donot significantly increase or decrease the diameter of the medicaldevice, or significantly adversely affect the function of the lowfriction coating.

SUMMARY

The present disclosure relates in general to medical devices, andspecifically to medical devices having low-friction (including lowfriction, low surface energy and/or non-stick) coatings having visiblemarkings, and a method for manufacturing the same.

In one embodiment, the medical device, such as a medical wire, includesa coating applied to the surface of the medical device. The coatingincludes a base layer bonded to the surface of the medical device and anat least partially low-friction top coat on the surface of the coating.The base layer includes pigments that change to a different, contrastingcolor when heated above a discoloration or color shifting temperature,or are otherwise stimulated by suitable stimulants. In one embodiment,the color of the pigment in one area contrasts with the color of thepigment in an adjacent area without otherwise affecting, degrading,deteriorating, compromising or changing the chemical composition of thelow-friction coating and/or significantly affecting, degrading,deteriorating, compromising or changing one or more characteristics,functions, or properties of the low-friction coating. The areas ofdifferent color created in locations along the length of thelow-friction coated medical device form markings which enable a surgeonor other medical professional to determine the length of the medicaldevice inserted into a body by observing the markings on the portion ofthe device located exterior to the body.

In one embodiment, a coating is applied to the surface of a medicaldevice, such as a medical wire. The coating includes a binder, at leastone heat-sensitive pigment, at least one relatively heat-stable pigmentand particles of a low-friction material such as PTFE. The medicaldevice and the applied coating are then heated above a designatedtemperature, such as 500° F. (260° C.) to cure the coating. The binderand heat sensitive pigment used in this method are generally stable atthe cure temperature, but one or both will discolor or shift color attemperatures above a specific temperature greater than 500° F. (260°C.). During the initial curing process, the low-friction particlessoften and at least some of the low-friction material migrates or flowsto the surface of the coating due to the different rates of curing ofthe low-friction particles and the binder. At or near the surface of thecoating, the low-friction material fuses or glazes over the base layerto create a smooth, substantially continuous top coat comprised oflow-friction material. Also during the curing process, the bindermaterial binds with the surface of the medical device and the heatactivated pigment is left interspersed within the binder material. Whencuring is complete, the medical device includes a base layer including abinder material and a heat activated pigment, and an at least partiallytransparent top coat substantially comprised of low friction or lowsurface energy materials. One advantage of this method over the aqueoussolution method of applying a coating is that the coating in this methodis cured at a lower temperature, which enables the heat sensitivepigment to be formulated to shift color at a lower temperature. Thelower color shifting temperature enables the color of the heat sensitivepigment (which is under the outer, relatively transparent low-frictioncoating) to shift without substantially affecting, degrading,deteriorating, compromising or changing the chemical composition of thelow-friction material of the coating and/or affecting, degrading,deteriorating, compromising or changing one or more characteristics,functions, or properties of the low-friction material of the coating.The lower color shifting temperature also enables the color of thepigment to shift without substantially affecting, degrading,deteriorating, compromising or changing one or more characteristics,properties, or functions of the adherence of the coating to the surfaceof the medical device.

After initially curing of the specific coating on the surface of themedical device, markings in the coating are created by selectivelyheating portions of the coating, including the heat activated pigment,above a color shifting temperature, or by selectively stimulatingportions of the coating by using a suitable external stimulant. Thecolor shifting temperature must be greater than the curing temperature,so that the pigment does not shift or change color during the curingprocess. The color shifting temperature must also be less than thetemperatures at which either the binder material significantly loses itsadhesion to the surface of the medical device, or the low-frictionmaterial of the coating substantially degrades. That is, if the colorshifting temperature is too high, then the low-friction character of thetop coat will degrade (nullifying the effectiveness of the low-frictioncoating), and the binder material will lose adhesion to the surface ofthe medical device (causing the coating to deteriorate, delaminate orpeel off) before the pigment can be heated above the color shiftingtemperature. A proper color shifting temperature enables areas ofdifferent or contrasting color to be created after curing and withoutadversely affecting the low-friction character of the top coat or theadhesion of the base layer to the surface of the medical device.Therefore, a proper color shifting temperature enables contrasting colormarkings to be created on the medical device without adversely affectingthe function of the medical device or the coating thereon.

In one embodiment, a first area of the low-friction coating is heated tothe color shifting temperature to shift or change the color of the heatactivated pigment for a specific distance, such as 3 mm as measured fromthe distal end, proximal end or from the center of the medical device.In this embodiment, a distance, such as 10 mm, is then measured from thefirst area to a second area. The second area, such as an area of 3 mm inlength, is subsequently heated to the color shifting temperature toshift or change the color of the heat activated pigment. Such heatingsto create areas of shifted color, when repeated in any sequence alongthe length of the device, result in specific length markings at measuredintervals. The markings of such width, depth or distance marked medicaldevices enable surgeons or other medical professionals to determine,based on a predetermined pattern known to the device user, the length ofthe medical device inserted into a patient, whether from the proximal ordistal end. Accordingly, the medical device and method disclosed hereinprovide the advantages of having specific markings that do notsignificantly increase or decrease the diameter of the medical device,or significantly adversely affect the function of the low-frictioncoating and further provide a coating over the base material of themedical wire or device.

In one embodiment, a coating is applied to the surface of a medicalwire. The medical wire is generally elongated and has a proximal end, adistal end, and at least one surface. The medical wire or device is madeof steel, stainless steel, aluminum, Nitinol, titanium, copper, plastic,ceramic, rubber, synthetic rubber or any other suitable material. Thecoating applied to the surface of the medical wire includes a binderresin (such as an epoxy, polyimide, polyetheretherketone (PEEK),polyetherketone (PEK), polyamide, PTFE or polyarylsulfone), and one ormore suitable pigments, such as any suitable heat activated pigment,organic pigment, inorganic pigment, extender pigment, magnetic receptivepigment, and/or laser receptive and excitable pigment. The coating alsoincludes particles of a low friction and/or low surface energy materialsuch as PTFE, fluorinated ethylene propylene (FEP), polyethylene (PE),perfluoroalkoxy (PFA) or any low surface energy particulate material.The coating is applied to the surface of the medical device and isadhered to the surface of the medical device by being cured by heatingthe coating to a designated temperature and for a designated period oftime to cure the binder resin. During the curing process, particles ofthe binder resin crosslink, sinter, or form bonds with other particlesof the binder resin and the substrate. The specially formulated binderresin also forms bonds with the surface of the medical device. Alsoduring the curing process, some of the low-friction material migrates orflows to the surface of the coating and fuses together to form asubstantially continuous glaze or top coat or outer surface oflow-friction material.

In one embodiment, after the coating is cured, portions of the heatactivated pigment are heated above the color shifting temperature. Inone embodiment, heat is selectively applied to a portion of the topcoat, which subsequently heats the base layer underneath the clear toplayer. In one embodiment, infrared or laser heat is applied to the baselayer by passing the radiated heat through the at least partiallytransparent top layer. In one embodiment, the medical device is heatedby induction and the base layer is heated by conduction from one or moredesignated portions of the heated coated medical device.

When the base layer is heated to a temperature above the color shiftingtemperature, the heat activated pigment changes color from a first colorto a second different color. The color of the pigment (within the matrixof the coating) is shifted in selected locations along the length of thedevice such that the different colors serve as visual indicia whichindicate a designated marking that may denote length of the medicaldevice or a designated position on the medical device. Using a jet ofhot air, open flame, plasma heat or other suitable mechanism orapparatus for applying heat, the color of a small length of the medicalwire in a first location is shifted such that the wire has a thin, 2 mmlong for example, band of different color around its circumference. Adistance, such as 10 cm, is then measured from the first location havinga different color to a second location along the length of the device.The second location is also selectively heated and caused to shift colorsuch that the wire has a second 2 mm long band of a different color. Inthis manner, repeated locations of shifted color along the length of thedevice indicate to surgeons or other medical professionals the length ofthe medical wire that is inserted into a patient.

It should be appreciated that the locations of shifted color can becreated in any suitable combination of lengths and patterns to indicatedifferent lengths and locations on the medical device. For example, asingle mark of 5 mm indicates a location in the exact center of a guidewire. In another example, a pattern of bands can provide a distancemarker from the distal end of a medical device. For example, from theexact center of a guide wire toward the distal end, 5 mm marks areprovided as a single mark 10 mm from the centerline, another 2 mm markis provided at 15 mm from the centerline, two bands of 5 mm spaced by 1cm are provided at 20 mm from the centerline, another band of 2 mm isprovided at 25 mm from the centerline followed by three 5 mm bands at 30mm from the centerline, and so on to the distal end of the device. Inanother example, a medical device disclosed herein includes a firstshifted color (which runs from a distal end of the medical device to ahalfway or middle point of the medical device) and a second, contrastingcolor (which runs from the proximal end of the medical device to thehalfway or middle point of the medical device). Such a configurationprovides that a surgeon or medical professional can quickly identifywhen more than 50% of the medical device is internal to the patient anddetermine whether a different medical device of a different lengthshould be employed. Such a configuration can also assist the surgeon ormedical practitioner in determining the length of a catheter or otherdevice which will subsequently be placed over the guide wire to aspecified distance, based on the markings on the exposed guide wire.Another mid-point marking system can be a series of 2, 3, 4 and 5 mmmarks preceding (and optionally succeeding) a centerline mark of two 5cm marks spaced apart by 1 cm, which denotes the exact centerline of thedevice. Such a marking system provides the surgeon a warning with thenarrower pattern of marks that the centerline is being approached.Accordingly, many marking codes or patterns can be used denotingdistance from the distal end of the medical device, the proximal end ofthe medical device, the centerline of the medical device or any suitablepoint or location of the medical device required by the medical devicemanufacturer.

In one alternative embodiment, a radiopaque material or compound, suchas barium sulfide, barium sulfate or a suitable metal, such as tungsten,is added to the coating. In this embodiment, a suitable marking isprovided or shows up using a suitable imaging device, such as an x-raydevice, a magnetic resonance imaging (MRI) device, or an ultrasounddevice. In one such embodiment, the imaging device displays an image ofthe radiopaque marking on one or more display devices of the imagingdevice. In another such embodiment, the imaging device produces an imageof the radiopaque marking on a film or other suitable media, such as byproducing an x-ray film. In these embodiments, the surgeon or othermedical professional utilize the imaging device to determine an exactlocation of the medical device inside a patient and/or to determine oneor more measurements inside the patient.

In another embodiment, a base layer including a radiopaque material isselectively bonded to a surface of the otherwise uncoated medicaldevice. For example, the radiopaque material is bonded to differentareas of the medical device to form discrete bands of the radiopaquematerial. In this embodiment, a suitable amount or density of theradiopaque material is selectively bonded to the surface of the medicaldevice such that the radiopaque material is detectable when the medicaldevice is viewed using a suitable imaging device. After selectivelybonding the radiopaque material to a surface of the medical device, thebase layer coated medical device (which includes the radiopaquematerial) is heated above a first designated temperature to cure thebase layer. After curing the medical device and the applied base layer,a low-friction material, such as PTFE, is applied to the base layercoated surfaces of the medical device and the uncoated surfaces of themedical device. The coated medical device and the low-friction materialare then heated above a second designated temperature to cure thecoating of the low-friction material. Thus, the medical device of thisembodiment includes a plurality of discrete markings of a radiopaquematerial covered by a low-friction top coating. Accordingly, theresulting medical device will have different slightly elevated areas orbands along the length of the medical device (such as to indicatedistance), have low-friction characteristics (including low friction,low surface energy and/or non-stick characteristics) and includemarkings that show up using an imaging device, such as an x-ray deviceor on an x-ray film, to provide an exact location of the medical deviceinside a patient for safety and/or measurement purposes.

In another embodiment, a base layer including a low-friction material,such as PTFE, is applied to a surface of the medical device. The medicaldevice and the applied base layer are then heated above a firstdesignated temperature to cure the coating. After curing the medicaldevice and the applied base layer, a radiopaque material is selectivelybonded to specified surface areas of the coated medical device. Thecoated medical device and the applied radiopaque material are thenheated above a second designated temperature to cure the radiopaquematerial For example, the radiopaque material is bonded to differentareas of the medical device to form discrete bands of the radiopaquematerial In this example embodiment, a suitable amount or density of theradiopaque material is selectively bonded to the surface of the coatedmedical device such that the radiopaque material is detectable when themedical device is viewed using a suitable imaging device. Thus, themedical device of this embodiment includes a plurality of discretemarkings of a radiopaque material above or otherwise bonded to alow-friction coating. Accordingly, the resulting medical device willhave different elevated bands or areas along the length of the medicaldevice (such as to indicate distance), have low-friction characteristics(including low friction, low surface energy and/or non-stickcharacteristics) and include markings that show up using a suitableimaging device, such as an x-ray device or on an x-ray film, to providean exact location of the medical device inside a patient for safetyand/or measurement purposes.

In another embodiment, as described above, certain areas of the medicaldevice are marked using color shifting pigments and radiopaque materialsare applied to certain other areas of the medical device. In one suchembodiment, a suitable radiopaque material is applied to a first portionof a medical wire that is inserted into a patient and a second portionof the medical wire that is not inserted into the patient is markedusing the above-described color shifting pigments. In this embodiment, asurgeon or other medical professional can utilize: (1) the portion ofthe medical wire that is inserted into the patient and a suitableimaging device, and (2) the visibly marked portion of the medical wirenot inserted inside the patient to determine the length of the medicalwire inserted into a patient's body, the length of certain elementsinside a patient, and the exact location of certain elements inside apatient.

In another embodiment, a first or base low-friction layer, including alow-friction material, such as PTFE, is applied to a surface of themedical device and suitably cured. In one such embodiment, the firstlow-friction layer includes a first relatively light colored pigment,such as a white colored pigment. After applying the first low-frictionlayer, a relatively thin (as compared to the first or base low-frictionlayer) second low-friction layer, including a low-friction material,such as PTFE, is applied to the coated surface of the medical device andsuitably cured to bond the two layers together. In one such embodiment,the second low-friction layer includes a second relatively dark coloredpigment, such as a green, black or blue colored pigment. In another suchembodiment, the second low-friction layer also includes one or morelaser receptive pigments.

After applying the two low-friction layers of contrasting color, asuitable laser and laser energy is selectively applied to differentareas of the coated medical device. In this embodiment, the laserablates or removes the relatively thin outer second low-friction layerwhile not adversely affecting the first low-friction layer. That is, thesecond low-friction layer with the relatively dark colored pigment (andoptionally the additional laser receptive pigments) absorbs the energy(or more of the energy) of the laser and is accordingly vaporized orablated from the coated surface of the medical device, while the firstlow-friction layer with a relatively light colored pigment does notabsorb the energy of the laser and is thus not affected by (or is notsignificantly affected by) the applied laser energy. After the laserenergy is selectively applied to different areas of the medical device,the resulting outer surfaces of the laser applied areas of the medicaldevice will include the first low-friction, light colored coating andthe outer surfaces of the non-laser applied areas of the medical devicewill include the second low-friction dark colored coating. It should beappreciated that since a thin layer of the dark colored low-frictionmaterial is applied to the medical device, when that thin layer isremoved from the medical device, any diametrical reductions of thediameter of the surface of the low-friction coating will be relativelyshallow and not create any substantially sharp edged shoulders which canscrape bodily tissues, snag vessels or arteries of the patient, orotherwise cause damage and/or trauma to virtually any part of thepatient's body. It should be appreciated that the laser energy whichcreates the ablation of the second or outer low-friction layer can bereduced along and nearest the edges or margins of the ablated area tocreate a tapering effect (i.e., a smoothening of the diametricaltransition) thus reducing the tactile feeling of a “notch” between thetwo layers of different colored coatings. Accordingly, in thisembodiment, different areas of the coated medical device are suitablymarked with different colors and the medical device includes at leastone suitable low-friction coating applied to the outer surface of themedical device such that the low-friction surface is always in contactwith the counter face or the tissue of the patient. As described above,such different colored areas along the surface of the low surfaceenergy, low-friction coated medical device provide a coated medicaldevice (without any unintentionally exposed metal portions) configuredto indicate to surgeons or other medical professionals the length of themedical device that is inserted into a patient.

In another embodiment, a first or base low-friction coating or layerincluding a low-friction material, such as PTFE, is applied to a surfaceof the medical device and suitably cured. In one such embodiment, thefirst low-friction coating includes a first colored pigment, such as arelatively light colored pigment. After applying the first low-frictioncoating, a suitable laser and laser energy is selectively applied todifferent areas of the coated medical device. In this embodiment, thelaser ablates or removes the first low-friction coating (at thedifferent areas of the medical device) to leave the bare metal substrateof the medical device exposed. After selectively removing one or moreportions of the first low-friction coating, a second low-frictioncoating or layer including a low-friction material, such as a coatingcomprised of Food and Drug Administration (“FDA”) listed non-objectioningredients or materials, is applied to the exposed bare metal substrateof the medical device and suitably cured. The second low-frictioncoating includes a second colored pigment, such as a relatively darkcolored pigment, wherein the second colored pigment contrasts the firstcolored pigment of the first low-friction coating. The applied secondlow-friction coating fills in part or all of the valleys which arecreated by laser ablating the first low-friction coating to provide thatdifferent areas of the coated medical device are suitably marked withdifferent, contrasting colors and that the medical device includes atleast one substantially continuous low-friction coating applied to theouter surface of the medical device. Such different colored areas alongthe surface of the low surface energy, low-friction coated medicaldevice provide a coated medical device configured to indicate tosurgeons or other medical professionals the length of the medical devicethat is inserted into a patient and/or to further indicate to thesurgeon or medical practitioner easily noted special characteristics ofa particular medical device.

In another embodiment, a first or base low-friction coating or layerincluding a low-friction material, such as PTFE, is applied to a surfaceof the medical device, such as a guide wire or other medical device madefrom a wire strand wound into a cylinder shape with a distal andproximal end. The first or base coating is then suitably under cured. Inone such embodiment, the first low-friction coating includes a firstcolored pigment, such as a relatively dark colored pigment. Afterapplying the first low-friction coating, a first end of the medicaldevice is held stationary or in place (such as by connecting the firstend to a suitable holder or clamp) and a second end of the medicaldevice is twisted or wound a designated number of rotations or turns,either clockwise or counterclockwise upon its longitudinal axis by asuitable twisting device. As described below, the designated number ofrotations or turns is determined based on how tight of a spiral patternis desired on the medical device and the length of the medical device,wherein the greater the number of complete rotations or turns of themedical device, the tighter the spiral pattern along the length of themedical device (i.e., the less distance between the center of eachadjacent spiral mark).

After twisting the second, free end of the medical device the designatednumber of turns, the second end of the medical device is secured (i.e.,to keep the medical device stretched and twisted), parts of the medicaldevice not desired to be further coated are protected, shielded ormasked and a second, low-friction coating or layer including alow-friction material, such as PTFE, is applied to one or moreunprotected, unshielded or unmasked portions of the coated surface ofthe medical device (i.e., the second low-friction coating is selectivelyapplied to the coated surface of the medical device). The secondlow-friction coating includes a second colored pigment, such as arelatively light colored pigment that contrasts the first coloredpigment of the first low-friction coating. In one such embodiment, thesecond low-friction coating is selectively applied along a longitudinalportion of the coated surface to form a linear strip or band along thelength of the coated surface of the twisted medical device. For example,along the length of the medical device, a thin stripe of the secondlow-friction coating is applied such as by spraying or rolling onto atop, unprotected or exposed portion of the coated surface of the twistedmedical device.

After applying the second low-friction layer to the desired portion ofthe twisted medical device, and drying or semi-curing the second appliedlayer so the second coat is sufficiently dry and physically stable, thefirst end and the second end of the medical device is untwisted orreleased (to enable the twisted medical device to unwind to a relaxed ornormal state). The coated medical device is then suitably final cured sothat both of the low-friction coatings are bonded to each other andbonded to the surface of the medical device. The resulting medicaldevice includes a spiral shaped pattern (around the circumference of themedical device) that extends along part or all of the length of themedical device. That is, the linear strip or band of the secondlow-friction coating that was applied when the medical device wastwisted becomes a spiral shaped strip or band of the second low-frictioncoating when the same medical device is untwisted and returns to theoriginal configuration. Such a medical device with longitudinal spiralmarkings enables a medical professional to determine if the insertedmedical device is rotating or moving as desired as the medical deviceenters the entry point of the patient's body. Such a medical device withlongitudinal spiral markings further enables a medical professional todetermine if their intended imparted motion of the medical device at theentry point of the patient resulted in causing the medical device toadvance, retract, rotate, be withdrawn or otherwise move in the patientby determining if the spiral markings appear to move. For example, theillusion of movement of the spiral markings of the medical device enablea medical professional to determine if the medical professional's glovedfingers are actually providing the tactile forces to move the medicaldevice as intended and that no unintended slippage of the medical deviceoccurred.

It is therefore an advantage of the medical device and method disclosedherein to provide a marked low-friction coated medical device havingmarkings which do not affect the function or form of the low-frictioncoating and enable a surgeon or other medical professional to determinethe length of a medical device inserted into a patient's body, and tomodulate the speed at which the medical device is being inserted orextracted from the patient's body. Such coated medical device providesno dynamic restrictions to any predetermined or required modulation ofspeed due to the removal or interruption of the low-friction coating tothe smooth, low-friction outer surface of the device. The medical deviceand method disclosed herein further provides a marked medical devicewith a smooth, continuous low-friction surface with a substantiallyconstant diameter which prevents the medical device from snagging,sticking, tearing, or otherwise damaging vessels, arteries, or othertissues of a patient during insertion, positioning, and extraction ofthe medical device. The low-friction coating is marked without otherwiseaffecting, degrading, deteriorating, changing the chemical compositionof, changing one or more characteristics, functions, or properties of orremoving in the entirety, the low-friction coating. The markedlow-friction coated medical device disclosed herein enables a surgeon orother medical professional to smoothly, easily, accurately, and safelyinsert and position the medical device in a patient's body during amedical procedure and know what distance is inserted into the patient'sbody and what distance remains outside of the patient's body. Themedical device and method disclosed herein further provides a markedmedical device with different slightly elevated bands or areas along thelength of the medical device (such as to indicate distance), havelow-friction characteristics (including low friction, low surface energyand/or non-stick characteristics) and include markings that show upusing a suitable imaging device, such as an x-ray device or on an x-rayfilm, to provide an exact location of the medical device inside apatient for safety and/or measurement purposes.

Additional features and advantages are described herein, and will beapparent from, the following Detailed Description and the figures.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a flow chart describing one embodiment of the disclosed methodof coating and marking a medical device.

FIG. 2 is a side view of one embodiment of a segment of an uncoatedmedical device disclosed herein.

FIG. 3 is a side view, partially in section, of the medical device ofFIG. 2 including an uncured coating applied to the surface thereof.

FIG. 4 is a side view, partially in section, of the medical device ofFIG. 3 after the coating is cured.

FIG. 5 is a side view, partially in section, of the coated medicaldevice of FIG. 4 including markings resulting from shifting the color ofselected areas of the base layer of the coating.

FIG. 6 is a side view of the coated medical device of FIG. 5.

FIG. 7 is a side view, partially in section, of the coated medicaldevice of FIGS. 5 to 6, including a laser for heating portions of thecoating of the coated medical device.

FIG. 8 is a side view of the coated medical device of FIGS. 5 to 6including a magnetic induction coil for heating portions of the coatedmedical device.

FIG. 9 is a side view of the coated medical device of FIGS. 5 to 6including markings having geometric shapes.

FIG. 10 is a side view of the coated medical device of FIGS. 5 to 6including markings having different colors.

FIG. 11 is a side view of the coated medical device of FIGS. 5 to 6including a progression of a plurality of interrupted colors along thelength of the medical device.

FIG. 12 is a side view of the coated medical device of FIGS. 5 to 6including a first shifted color which runs from a distal end of themedical device to a halfway or middle point of the medical device and asecond, different, contrasting color which runs from the proximal end ofthe medical device to the halfway or middle point of the medical device.

FIG. 13 is a side view of the coated medical device of FIGS. 5 to 6including a plurality of pigments having different color shiftingcharacteristics, wherein certain portions of the coating include aplurality of pigments that shift color.

FIG. 14 is a side view, partially in section, of the medical device ofFIG. 2 including a low-friction coating applied to the surface thereof.

FIG. 15 is a side view, partially in section, of the medical device ofFIG. 14 after a plurality of bands of a radiopaque material are appliedto the low-friction coating of the medical device.

FIG. 16 is a side view, partially in section, of the medical device ofFIG. 2 including a plurality of bands of a radiopaque material appliedto the surface thereof.

FIG. 17 is a side view, partially in section, of the medical device ofFIG. 16 after a low-friction top coat is applied to bands of theradiopaque material and the uncoated portions of the medical device.

FIG. 18 is a side view of a medical device of FIG. 2 including a firstportion of the medical device which illustrates a plurality of markingsresulting from shifting the color of selected areas of a base layer of acoating and a second portion of the medical device which illustrates aplurality of bands of radiopaque material and a low-friction coating.

FIG. 19 is a side view, partially in section, of the medical device ofFIG. 2 including a first low-friction coating applied to the surfacethereof.

FIG. 20 is a side view, partially in section, of the medical device ofFIG. 19 after a second low-friction coating is applied to the coatedsurface of the medical device.

FIG. 21 is a side view, partially in section, of the coated medicaldevice of FIG. 20 after areas of the second low-friction coating havebeen removed.

FIG. 22 is a side view of a coated medical device of FIG. 21 including afirst area with the applied second low-friction coating and a second,horizontal line shaped area with the second low-friction coatingremoved.

FIG. 23 is a side view of the coated medical device of FIG. 22 includinga plurality of areas of the second low-friction coating removed to forma plurality of markings along the length of the medical device.

FIG. 24 is a side view of the coated medical device of FIG. 22 includinga plurality of markings along the length of the medical device whichresult from applying energy to energy sensitive particles in the coatingto shift the color of selected areas of the coating.

FIG. 25 is a side view of a coated medical device of FIG. 21 including afirst area with the applied second low-friction coating and a second,spiral shaped area with the second low-friction coating removed.

FIG. 26 is a side view of the coated medical device of FIG. 25 includinga plurality of areas of the second low-friction coating removed to forma plurality of markings along the length of the medical device.

FIG. 27 is a side view of the coated medical device of FIG. 25 includinga plurality of markings along the length of the medical device whichresult from applying energy to energy sensitive particles in the coatingto shift the color of selected areas of the coating.

FIG. 28 is a side view, partially in section, of the medical device ofFIG. 2 including a first low-friction coating applied to the surfacethereof.

FIG. 29 is a side view, partially in section, of the medical device ofFIG. 28 after areas of the first low-friction coating have been removed.

FIG. 30 is a side view, partially in section, of the coated medicaldevice of FIG. 29, after a second low-friction coating is applied to theareas in which the first low-friction coating was removed.

FIG. 31 is a flow chart describing another embodiment of the disclosedmethod of coating and marking a medical device, such as medical guidewire.

FIG. 32A is a greatly enlarged fragmentary sectional side view of oneembodiment of a segment of an uncoated medical guide wire disclosedherein.

FIG. 32B is an end view, partially in section, of the uncoated medicalguide wire of FIG. 32A.

FIG. 33A is a greatly enlarged fragmentary side view, partially insection, of the medical guide wire of FIG. 32A including a firstlow-friction coating applied to the surface thereof.

FIG. 33B is an end view, partially in section, of the medical guide wireof FIG. 33A.

FIG. 34A is a greatly enlarged fragmentary side view, partially insection, of the medical guide wire of FIG. 33A after a first end of themedical guide wire has been secured and a second, free end of themedical guide wire has been turned a designated quantity of times uponits longitudinal axis.

FIG. 34B is an end view, partially in section, of the twisted medicalguide wire of FIG. 34A.

FIG. 35A is a greatly enlarged fragmentary side view, partially insection, of the twisted medical guide wire of FIG. 34A including asecond low-friction coating selectively applied to the surface thereof.

FIG. 35B is an end view, partially in section, of the twisted medicalguide wire of FIG. 35A.

FIG. 36 is a greatly enlarged fragmentary side view of the untwistedcoated medical guide wire of FIG. 35A including a plurality of areas ofthe second low-friction coating which form a plurality of spiralmarkings along the length of the medical guide wire.

FIG. 37 is a side fragmentary view of the coated medical guide wire ofFIG. 35A including a plurality of areas of the second low-frictioncoating which form a plurality of spiral markings along the length ofthe medical guide wire.

FIGS. 38A, 38B, 38C, 38D and 38E are top sectional views of the coatedmedical guide wire described herein, illustrating the linear strip ofthe second low-friction coating applied to the twisted medical guidewire forming a spiral marking as the medical guide wire untwists.

DETAILED DESCRIPTION

For the purposes of this application only, the medical device isreferred to and illustrated as a medical wire or a medical guide wire.However, the medical device disclosed herein is any device that isinserted into a patient or connects to a device that inserts a deviceinto a patient in connection with any medical procedure. Such medicaldevices include, but are not limited to medical wires, medical guidewires, catheters, needles, soft tissue needles, biopsy devices, biopsytubular sampling devices, soft tissue biopsy devices, soft tissuetubular devices, hook-type biopsy devices, cannulas, probes,electrosurgical electrodes, blades and knives. The medical device isconstructed from any suitable material, including but not limited tometals such as steel (both high- and low-carbon content), stainlesssteel, aluminum, titanium, copper, nickel, silver, nitinol, and othermetals and metal alloys. Other suitable materials of which a medicaldevice may be constructed include ceramics, rubber, any suitable polymermaterial and any suitable plastic, including but not limited to nylon,polyetheretherketone (PEEK), polyetherketone (PEK),polyphenylenesulphide (PPS), acrylonitrile-butadiene-styrene (ABS),polycarbonate, epoxy, polyester, and phenolic, or any combinationthereof. It should be appreciated that various changes and modificationsto the presently preferred embodiments described herein will be apparentto those skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages.

In one embodiment, the medical device illustrated in FIG. 2, is anmedical wire before having a coating applied thereto. The medical wire200 is generally elongated and has a proximal end 202, a distal end 204,and an outer surface 206. In one embodiment, the medical device is amedical guide wire, wherein the guide wire includes one or moreelongated strands of coated medical wire helically wound such thatadjacent turns of the wire are in contact with each other. The resultingmedical guide wire is generally shaped like a coiled spring and includesa proximal end and a distal end.

In one embodiment, referring to FIG. 1, before applying a coating to thesurface of the medical device, in this case a medical wire, the medicalwire is prepared for coating as indicated in block 100 of FIG. 1. In onesuch embodiment, the medical wire is cleaned with a cleaner to removeimpurities which are present on the surface of the medical wire.Impurities such as oils may impede bonding of a coating to the surfaceof the medical wire, and also may cause damage to a patient if insertedinto a patient's body during a medical procedure. The cleaner, such as asolvent, acid solution or alkaline, is suitably applied, such asmanually applied, mechanically applied or ultrasonically applied to themedical wire. In another embodiment, the medical wire is cleaned bycondensing a vaporized cleaner on the surface of the medical wire,wherein the cleaner dissolves and washes away the oils on the surface ofthe medical wire. In another embodiment, laser energy from a laserdevice, such as a YAG laser, is directed at the surface of the medicalwire to clean the surface of the medical wire.

In another embodiment, grit blasting, tumble blasting, or sandblastingwith a medium such as aluminum oxide, garnet, or silicone carbide isused to clean the surface of the medical wire and create a roughenedsurface which promotes bonding with a coating. In another embodiment,the surface of the medical wire is etched with acid or alkaline to cleanand roughen the surface of the medical wire. In another embodiment,laser energy from a laser device, such as a YAG laser, is directed atthe surface of the medical wire. In this embodiment, the laser deviceprovides sufficient energy to roughen the outer surface of the smoothmedical wire resulting in a textured, matte, or generally non-smoothsurface to the medical wire. Such a non-smooth surface promotes adhesionof subsequently applied coatings, without the abrasive dust produced bymechanical abrasion.

In another embodiment, the medical wire is cleaned with an ultrasoniccleaner used in combination, prior or after the ultrasonic degreaser,with a solvent such as acetone, alcohol or another degreaser.Alternatively, the medical wire is pre-cleaned or the method isperformed in a “clean room” where the cleaned part is manufactured andthe step is not necessary. In another embodiment, the medical wire isheated to a temperature, depending on the metal alloy or other materialof the medical wire, in excess of at least 700° F. (371° C.) for aperiod of time sufficient to thermally degrade surface impurities, drawoils and other impurities out of any pores in the surface of the medicalwire and create a non-acidic “passivation” of the surface of the medicalwire. In another embodiment, the medical wire is cleaned in a batch orbulk cleaning method, thereby cleaning all of the surfaces of themedical wire. In another embodiment, the medical wire is heated beforeapplying a coating to reduce ambient moisture on the surface of themedical wire and improve adhesion of a coating to the medical wire. Inanother embodiment, the medical wire is cleaned with a grit-blastingsystem which includes several grit-blasting nozzles cleaning the surfaceof the medical wire with relatively high velocity particles of anabrasive such as aluminum oxide or silicon carbide. In otherembodiments, any combination of the cleaning methods mentioned above areused to improve the cleaning process and promote adhesion of a coatingto the medical wire.

After preparing the medical wire for coating, a coating is applied toone or more surfaces of the medical wire as indicated in block 102 ofFIG. 1. Referring to FIG. 3, the coating 208 includes a binder 210 a,such as an epoxy, phenolic, phenoxy, polyimide, polyamide,polyamide-amide, polyphenylene sulfide, polyarylsulfone, polyethylene,polytetrafluoroethylene, fluorinated ethylene propylene,perfluoroalkoxy, polyetheretherketone (PEEK), polyetherketone (PEK), orany suitable binder or resin. Such suitable binders include any binderwhich, when cured, adheres to the surface of the medical device, and isflexible, stable, resistant to chemicals, and/or is readily sterilizedand resistant to contamination. In one embodiment, the coating includesan ultraviolet light cure resin to semi or fully cure the coating. Inanother embodiment, the coating includes an electron beam cure resin.

The coating also includes at least one pigment 212 a such as anysuitable organic pigment, inorganic pigment, extender pigment, magneticreceptive pigment and/or laser excitable pigments. The organic pigments(with low to moderate heat resistance and which are represented asbright colors) include, but are not limited to, phthalocyanine blues andgreens, diarylide yellows and oranges, quanacridone, naphthol andtoluidine reds, carbizole violets, and carbon black. The inorganicpigments (with moderate to high temperature resistance and which arerepresented as dull to moderately bright colors) include, but are notlimited to, iron oxide reds and yellows, chrome oxide greens, titaniumoxide white, cadmium reds, ultramarine blues, moly oranges, leadchromate yellows, and mixed metal oxides of various shades of brown,yellow, blue, green and black. The extender pigments (which areinorganic and provide a reinforcing/strengthening function) include, butare not limited to, talc, calcium carbonate, silicate and sulfate,silica, mica, aluminum hydrate and silicate, and barium sulfate (blancfixe/barites). The laser exciteable pigments (which are excited by laserenergy), such as near-infrared reflective pigements include, but are notlimited to, mica, pearl pigment, Kaolin and aluminum silicatederivatives, antomony trioxide, metallic pigment, aluminum flakepigment, and iron oxide. Additionally, the coating may also include oneor more of the following functional pigments, such as conductivepigments, flattening pigments for controlling gloss, clays and otherrheology modifying pigments.

In one embodiment, a coating which is formulated with magnetic receptivepigments and/or electromagnetic receptive pigments is utilized, whereinthese magnetic receptive pigments will provide internal heat whensubjected to one or more appropriate magnetic fields or electromagneticfields. In this embodiment, such magnetic receptive pigments are appliedto non-magnetic substrates, such as non-magnetic stainless steel,ceramics, plastic or polymers. Such magnetic receptive pigments areformulated with low-friction materials and appropriate color pigmentsand binders, such as epoxy and polyimide, which when cured at a suitabletemperature provides adhesion to the substrate and also creates thelow-friction surface. In this embodiment, the medical device issubsequently internally heated by exciting or energizing the dispersedmagnetic receptive particles, which causes select areas of the medicaldevice to change colors from the primary color to a darker color in theareas where the coated device is selectively subjected to the magneticforces, while not overheating either the binder resin or the outer layerof low-friction material.

The pigment is configured to change color when heated above a colorshifting temperature. The color shifting temperature is greater than,such as by 50-100° F. (10-38° C.), the designated temperature at whichthe coating is cured to allow the coating to be cured without changingthe color of the pigment during the curing process. The color shiftingtemperature of the heat activated pigment should also be lower than thetemperatures at which either the low-friction characteristics of thelow-friction material, or the adhesive characteristics of the binderresin, are substantially affected, degraded, or deteriorated, or thechemical composition, characteristics, functions, or properties of thelow-friction coating and/or base resin are changed.

The coating also includes particles of a low-friction material 214 asuch as PTFE or PE. After curing, the low-friction material forms an atleast partially transparent top coat such that at least some visiblelight passes through the low-friction material. In one embodiment, theparticles are micron- and/or sub-micron-sized. In another embodiment,the low-friction material is resistant to chemicals such that thelow-friction material will provide a low surface energy outer layer andwill resist corrosion, resist oxidization, resist breaking down, resistforming bonds with other materials, and otherwise be unaffected bycontacting other chemicals. In another embodiment, the low-frictionmaterial is pure and free of contaminants such that the low-frictionmaterial can safely be used in medical procedures and can safely contactfood for human consumption. In another embodiment, the low-frictionmaterial is irradiated, prior to incorporation in the coating, with anelectron beam (or other suitable energy source) so that the resultingparticles create an easily wetted surface which enables better adhesionto the binder material.

In another embodiment, the coating includes additives, such as silanecoupling agents, other materials formulated to improve the bondingcapabilities of a coating to the surface of the medical wire,particularly smooth surfaces, or other materials which modify the curingcharacteristics or the drying characteristics of the coating beforecuring. In another embodiment, the coating includes additives to improvethe wear characteristics, corrosion resistance, and/or electricalproperties of the coating. For example, in one embodiment, the uncuredcoating includes approximately 30%-50% by volume of a base resin, 1%-30%of a heat stable pigment, and 0.5%-15% of a pigment that shifts from afirst color to a second, contrasting color when heated from a firsttemperature to a second temperature which is 20-200° F. (11-93° C.)higher than the first temperature. The uncured coating also includes2%-10% by volume of low-friction particles and trace amounts of awetting agent, a silane coupling agent, a hardening agent, and/or curingor drying agents. In another embodiment, an alcohol (or other suitablesolvent) and a silane coupling agent (or other suitable adhesionpromoting agent) are utilized as a primer dip on the smooth orsemi-smooth surface of the medical device. For example, a dilute mixtureof 2-3% silane in alcohol is applied to the medical device prior to theapplication of any suitable top coats followed by an appropriate curingprocedure to bond the silane to the surface of the coated medical deviceto promote adhesion of any subsequently applied top coats.

In one embodiment, a coating is applied by spraying the surface of amedical wire with the coating. In one embodiment, the coating is sprayedon, applied using a air atomizer or appropriate atomizing device,applied by a siphon, gravity, ultrasonic or pressure pot method whichforces the coating through a nozzle at high pressure such that thecoating forms a vapor or mist which is directed toward the surface ofthe medical wire. In another embodiment, the coating is applied with avariation of siphon or gravity spraying wherein the coating is sprayedat a lower pressure and in higher volume to reduce the amount ofvolatile organic compounds released during the spraying process. Inanother embodiment, a medical wire device is dipped into a reservoirfilled with the coating. Once submerged, the medical device or wire isremoved from the reservoir and “spun” or rapidly rotated to removeexcess coating by centrifugal force. In another embodiment, a medicaldevice or wire is “tumbled” in a rotating barrel or other rotatingenclosure including a coating. Hot air is blown over the tumblingmedical wire to at least partially cure the coating as it is applied tothe medical wire. In another embodiment, high speed rollers are used toapply a film of coating to the surface of a medical wire. In anotherembodiment, a medical wire is passed under a falling curtain of thecoating to coat the surface of the medical wire. In another embodiment,an electrical current is passed thru an aqueous bath containing theappropriate particles and such particles are adhered to the medical wireusing positive and negative differentials in voltage between the bath ofparticles and the medical wire. In this embodiment, such deposition isregulated by the combination of electrical energy and the chemistry ofthe bath containing the particles and resins and agents that provide theproper characteristics once cured to the medical device.

In another embodiment, a powder coating system is employed. This powdercoating system includes a primer, where required, of a liquid that ispreapplied and either cured to dry or remains wet prior to theapplication of a topcoat of a powder. In this embodiment, the powder mayinclude a low-friction material such as PFA, FEP, PTFE, PE, PEEK, PEK orappropriate low-friction particles or a combination of the above plusappropriate pigments similar to those described in the liquid-typecoatings described above.

In another embodiment, an electrostatic, tribo-charged or oppositeelectrostatic charged spray or powder spray method is used to apply thecoating to a medical wire. The electrostatically charged spray enablesan operator to better control the application uniformity of the coatingand thereby enhances the uniformity, density and application of thecoating on the surface of the medical wire. It should be appreciatedthat the coating may have one or more characteristics altered to allowfor more efficient electrostatic, tribo-charged or oppositeelectrostatic charged spray techniques to be used to apply the coatingto a medical wire.

Moreover, the above-described “tribo-charge”, or electrically charged aswith conventional electrostatic application technique alters the edgecoverage thickness of the applied coating based on any designrequirements which require a more uniformly applied coating to allsurfaces of the medical wire, whether the configuration has sharp orround edges. This technique results in greater coating transferefficiency while also optimizing the different edge coverage thicknessesof the applied coating, whether the medical device is a medical wire,medical guide wire, catheter, needle, knife, cannula, probe, or othermedical device.

Referring to FIG. 3, one embodiment of the medical wire is illustratedwherein the medical wire includes an uncured coating 210 applied to itssurface. After the coating is applied to the surface of the medicalwire, the coating is cured as indicated in block 104 of FIG. 1 to hardenthe coating and strengthen the bond between the coating and the medicalwire, thereby curing the coating. The curing process is performed byheating the coating at a predetermined temperature or temperatures for apredetermined length or lengths of time, air-drying the coating atambient temperature, or by utilizing any suitable internal or externalcuring process. It should be appreciated that curing may be accomplishedby exposure to light from an infrared, visible, or ultraviolet lightsource.

In one embodiment, as illustrated in FIG. 4, during the curing process,the molecules of a binder, such as an epoxy 210 a crosslink and formchemical bonds with each other, and bond with the surface of the medicalwire. The crosslinked epoxy molecules form an epoxy matrix 216 includingcrosslinked binder molecules, one or more low-friction materials, one ormore pigments, and one or more other ingredients such as wetting agents,coupling agents, hardening agents, and/or other additives. Also duringthe curing process, the particles of low-friction material such as FIFE214 b soften and at least some of the PTFE or other low-frictionmaterial is squeezed out or displaced from the epoxy matrix andmigrates, rises, or flows to the surface of the coating. At or near thesurface of the coating, the PTFE molecules bond or fuse together to forma thin, partially transparent top coat 218 of PTFE on the outer surfaceof the coating. When the curing process is complete, as illustrated inFIG. 5, the coating includes a base layer including the epoxy matrix,and a top coat including fused molecules of PTFE. It should beappreciated that when the coating is cured, the epoxy matrix exhibits afirst color, such as light blue, which is visible through the at leastpartially transparent PTFE top coat. Also, the surface of the coating212 is smooth and resists sticking to other objects, which enables asurgeon or other medical professional to gently, smoothly, andaccurately insert one end of the coated medical wire 220 into apatient's body.

Referring now to FIG. 5 and FIG. 6, in one embodiment, after curing theapplied coating to harden the coating and form a low-friction top coat,markings 220 a and 220 b are created on the coated medical device orwire as indicated in Block 106 of FIG. 1. The markings are created byselectively heating portions of the coating above a color shiftingtemperature while simultaneously maintaining adjacent portions 222 a,220 b, and 220 c at a cooler temperature (with a suitable maskingdevice). When heated above the color shifting temperature, the pigmentin the selectively heated portions changes from a first color to asecond color. For example, in one embodiment, as illustrated in FIG. 5,the coating applied to the medical wire is generally light blue incolor. However, at measured intervals along the length of the medicalwire, short sections of the base layer of the coating are dark brown orblack (i.e., contrasting) in color. Thus, a first segment such as a 100mm long segment of the coated medical wire is light blue in color. Asecond adjacent segment such as a 3 cm long segment of the coatedmedical wire is dark brown in color, and a third segment such as a 50 mmlong segment, adjacent to the second segment, is light blue in color.The pattern of alternating light blue and dark brown or black segmentsis repeated from the proximal end to the distal end of the coatedmedical wire, resulting in a coated medical wire having markings whichvisually indicate each 50 mm of length of the coated medical wire. Itshould be appreciated that the color transitions of the coated medicaldevice may be absolute (i.e., a first color ends and a second,contrasting color begins) or gradual or feathered (i.e., a first colorbleeds into a second, transitioning color which bleeds into a thirdcolor which contrasts with the first color). The markings enable asurgeon or other medical professional to determine the length of thecoated medical wire inserted into a patient's body (or the length of thecoated medical wire remaining outside the patient's body) during amedical procedure.

Referring to FIG. 7, in one or more embodiments, the pigment in thecoating is heated above the color shifting temperature by radiated heat.Radiated heat is applied from any radiant source, such as hot air, openflame, heated filaments, or lasers 226. Radiated heat can be directed tospecific portions of the coating by masking portions of the coating(with a suitable masking device) that are not intended to be heatedabove the color shifting temperature. Masking is accomplished by anysuitable mechanism configured to shield the coating from the heatsource. In one embodiment, hot air is blown toward a specific portion ofthe coating through a nozzle or other apparatus of directing orfunneling air. In another embodiment, heat is directly applied to thesurface of the medical device such that intimate contact occurs betweenthe heat source and the coated surface. In another embodiment, whenradiated or infrared heat is directed to a portion 224 of the coating,the at least partially transparent top coat allows certain designatedamounts of radiated or infrared heat to pass through the top coat to thebase layer, which absorbs the heat. This method heats the base layerwhile simultaneously keeping the low-friction top coat at a slightlycooler temperature, which has the advantage of preserving thelow-friction character of the top coat and maintains the at leastpartial transparency of the top coat.

Referring to FIG. 8, in one embodiment, the medical wire, which in thiscase is formed from a magnetic-type stainless or otherwise appropriatesteel, is heated by magnetic induction wherein an induction coil 230 isenergized with a frequency current, which imparts thermal energy in themedical wire. Electrical resistance in the medical wire causeselectrical current energy to transform into heat energy. Heat from themedical wire then transfers to the base layer by thermal conduction,thus shifting the color of the portion of the base layer 228 above theheated segment of the medical wire. This method also has the advantageof keeping the low-friction top coat at a slightly cooler temperature,which preserves the low-friction character of the top coat. It should beappreciated that any suitable external energy source, such as flameheat, short wave infrared, medium wave infrared, hot air (electricallyheated) with accurately placed orifices to make a specific and accuratemarks on the medical wire, induction heat provided through a “bobby pin”or circular shaped coil and/or at right angles, and/or heat providedusing induction energy may be used to stimulate the pigment and/orbinder resin to cause the pigment and/or binder resin to be heated toshift color.

In different embodiments, radiation, microwaves, concentrated soundwaves or other vibrations, or other external energy sources may also beused to selectively stimulate the pigment and/or binder resin to causethe pigment and/or binder resin to shift color. In another embodiment,laser energy, such as provided by a CO₂ (carbon dioxide), YAG lasers(Ytterbium), and fiber laser systems, provide the necessary energy toselectively stimulate the pigment and/or binder resin to cause thepigment, additive and/or binder resin to shift color. In thisembodiment, these lasers have different depths of penetration, different“dot” sizes and/or different energy outputs which can be pulsed toselectively stimulate the pigment and/or binder resin to cause thepigment and/or binder resin to shift color.

In one embodiment, the medical device disclosed herein is coated, curedand selectively heated in sequential order. For example, a 180 mm longmedical wire is entirely coated, entirely cured and then selectivelyheated exactly in the center to a width of 5 cm to cause the pigmentand/or binder resin to shift color. In another embodiment, differentportions of the medical device are coated, cured and selectively heatedsimultaneously. For example, a first 1 foot (30.4 cm) long portion of a5 foot long (152.4 cm) medical wire is coated, while a second, different1 foot (30.4 cm) long portion of the 5 foot (152.4 cm) long medical wireis cured, while a third, different 1 foot (30.4 cm) long portion of the5 foot (152.4 cm) long medical wire is selectively heated to cause thepigment and/or binder resin to shift colors. In these embodiments, themedical device is coated in a suitable coater or utilizing a suitablecoating device, the medical device is cured in a suitable curer orutilizing a suitable curing device and the medical device is selectivelyheated with a selective heater or utilizing a suitable selective heatingdevice.

In one embodiment wherein the medical device is a medical guide wiregenerally having the shape of a coiled spring, after the guide wire isformed, segments of the guide wire are selectively heated to shift thecolor of the heat activated pigment. The method of marking helicallywound medical guide wire disclosed herein has the advantage of creatingpermanent markings at measured intervals along the length of the medicalguide wire without weakening the medical guide wire, without creatingdebris or the potential for debris that could get caught between theadjacent coils of the medical guide wire, and without removing thelow-friction coating or adversely affecting the function of thelow-friction coating.

In another embodiment, a plurality of pigments having different colorshifting temperatures are included in the coating. By selectivelyheating portions of the coating above the color shifting temperature ofa first pigment but below the color shifting temperature of a secondpigment, the color of the coating can be changed from a first color to asecond different color. By selectively heating portions of the coatingabove the color shifting temperature of the second pigment, the color ofthe coating can be changed from the first color to a third differentcolor. In one embodiment, for example, a coated medical wire includes abase color such as light blue, length markings in a second color, suchas tan, and a second set of markings, such as a company logo,specifications, or use instructions in a third color such as brown orblack.

In one embodiment, markings are created in the coating in any desiredpattern or colors, or any combination of patterns and colors. In onesuch embodiment, the size of the markings and/or the number of marksgrouped together to form a marking indicate different lengths of themarked medical device. In another such embodiment, small markings can becreated at measured intervals along the length of the coated medicalwire to indicate uniform length markers of the coated medical wire. Inanother embodiment, markings are created to indicate a specific distancefrom a reference point on the coated medical wire, such as a distancefrom the middle point, the proximal end and/or the distal end. Forinstance, one band having a shifted color can indicate a first distancefrom the distal end, while two bands having shifted colors in closeproximity can indicate a second distance from the distal end. Likewise,in another embodiment, depending on the size and shape of the medicaldevice, numbers or characters are created in the coating to indicate adistance from a middle point, the distal end and/or the proximal end. Inanother embodiment, as illustrated in FIG. 9, one or more geometricshapes, including but not limited to circles 240, squares 242,rectangles 244, triangles 246, parallelograms 248, and other polygramsare created in the coating to indicate lengths of the medical device.

In another embodiment, a plurality of different colors are created toindicate distances from the middle point, proximal end or distal end ofthe medical device. The different colors are created by selectivelyheating a plurality of different pigments (with different properties andcolor shifting temperatures) above their respective color shiftingtemperatures. For example, in one embodiment, a progression of aplurality of uninterrupted colors is created along the length of themedical device. For illustrative purposes only, FIG. 10 illustrates oneembodiment wherein a first 30 mm segment 250 of the coating of themedical wire is a first color. A second 30 mm segment 252 of the medicalwire adjacent to the first segment is a second color. The adjacentsegments 254, 256, and 258, each 30 mm long, are also each differentcolors. It should be further appreciated that a combination of one ormore marking methods disclosed herein can provide a surgeon or othermedical professional with additional information about the medicaldevice. For example, the embodiment of FIG. 10 includes segments ofdifferent colors and also includes equally spaced markings of a firstcolor, wherein the markings each indicate 10 mm of length.

In another embodiment, a progression of a plurality of interruptedcolors is created along the length of the medical device. Forillustrative purposes only, FIG. 11 illustrates one embodiment wherein afirst segment 260 of the coating of the medical wire is a first color, asecond segment 262 a of the medical wire adjacent to the first segmenthas not been selectively heated and is a default, second color of thecured base material. For this example, a third segment 264 of thecoating of the medical wire is a third color, a fourth segment 262 b ofthe medical wire adjacent to the third segment has not been selectivelyheated and is the default, second color of the cured base material and afifth segment 266 of the coating of the medical wire is a fourth color.

In another embodiment, a medical device disclosed herein includes afirst shifted color (which runs from a distal end of the medical deviceto a halfway or middle point of the medical device) and a second,different, contrasting color (which runs from the proximal end of themedical device to the halfway or middle point of the medical device).For illustrative purposes only, FIG. 12 illustrates one embodimentwherein a first segment 268 of the medical wire (which runs from thedistal end of the medical wire to a middle point) is coated andselectively heated to a first color shifting temperature to change thecolor of a first pigment (and thus change the color of the firstsegment) to a first color, such a green. As further seen in FIG. 12, asecond segment 270 of the medical wire (which is of equal orsubstantially equal length as the first segment and runs from theproximal end of the medical wire to the middle point) is coated andselectively heated to a second color shifting temperature to change thecolor of a second, different pigment (and thus change the color of thesecond segment) to a second, different color, such as yellow. Such aconfiguration provides that a surgeon or medical professional canquickly identify when more than 50% of the medical device is internal tothe patient and determine whether a different medical device of adifferent length should be employed. That is, the medical device of thisembodiment (and other disclosed embodiments wherein different segmentsof a medical device are marked with different colors) is utilized by asurgeon or medical professional during a medical procedure to determinethe length of the medical device inserted into a patient's body (i.e.,by observing the color of the segments of the medical device that areexternal to the patient's body).

In another embodiment, a plurality of pigments having different colorshifting characteristics are included in the coating, wherein certainportions of the coating include a plurality of pigments that shiftcolor. For illustrative purposes only, FIG. 13 illustrates oneembodiment wherein a first segment 272 of the medical wire (whichaccounts for 25% of the length of the medical wire) is coated andselectively heated to a first color shifting temperature to change thecolor of a first pigment (and thus change the color of the firstsegment) to a first color, such as yellow. As further seen in FIG. 13, asecond segment 274 of the medical wire (which accounts for another 25%of the length of the medical wire) is coated and selectively heated to asecond color shifting temperature to change the color of a secondpigment (and thus change the color of the second segment) to a secondcolor, a third segment 276 of the medical wire (which accounts foranother 25% of the length of the medical wire) is coated and selectivelyheated to a third color shifting temperature to change the color of athird pigment (and thus change the color of the third segment) to athird color and a fourth segment 278 of the medical wire (which accountsfor another 25% of the length of the medical wire) is coated andselectively heated to a fourth color shifting temperature to change thecolor of a fourth pigment (and thus change the color of the fourthsegment) to a fourth color. In this example, in addition to using heatactivated pigments to shift the colors of the four segments, additionalmarkings 280 a to 280 h are created along the length of the medical wireby utilizing laser activated pigments to selectively change certainportions of the medical wire a fifth color. That is, although one ormore pigments located in the coating of the first segment of the medicalwire were previously heat activated to change the first segment to ayellow color, additional pigments located in the coating of the firstsegment are laser activated to indicated marks 280 a and 280 b as abrown color in the first segment. Such a configuration provides that asurgeon or medical professional could utilize not only the color of thedifferent segments of the medical device (i.e., to determine the lengthof the medical device inserted into a patient's body by observing thecolor of the segments of the medical device that are external to thepatient's body) but could also count the number of marks for a segmentthat is partially internal and partial external to the patient's body todetermine the exact length of the medical device utilized.

In another such embodiment which utilizes a plurality of pigments havingdifferent color shifting characteristics in the coating (not shown), afirst segment of a coated medical device (which runs from the distal endof the medical wire to a middle point of the medical device) isselectively heated to a first color shifting temperature to change thecolor of a first pigment (and thus change the color of the firstsegment) to a first color, such a black. In this embodiment, a secondsegment of the medical device (which runs from the proximal end of themedical wire to the middle point) is then selectively heated to a secondcolor shifting temperature to change the color of a second, differentpigment (and thus change the color of the second segment) to a second,different color, such as yellow. In this embodiment, a third pigmentlocated in certain portions of the first segment of the medical deviceare excited or otherwise activated to change to a third color, such aswhite (and thus create suitable markings in the first segment of themedical device) and a fourth pigment located in certain portions of thesecond segment of the medical device are excited or otherwise activatedto change to a fourth color, such as brown (and thus create suitablemarkings in the second segment of the medical device).

It should be appreciated that the markings disclosed herein are notlimited to indicating lengths, but also can indicate the size, type,material, part number, serial number, lot number, manufacturing date,manufacturer of the coated medical wire or medical device. The markingscan also include bar codes or other codes, or other properties orinstructions associated with the coated medical wire or medical device.In another embodiment, the markings disclosed herein form a band orstripe along the entire length or along selected lengths from the distalend to the proximal end of the medical device. In different embodiments,these markings can form one or more: linear lines, bands or stripesalong the longitudinal axis of the medical device, spiral patternedlines, bands or stripes along the length of the medical device, parallellines, bands or stripes, perpendicular lines, bands or stripes,transverse lines, bands or stripes, any indicia or marking disclosedherein or any combination thereof. It should be appreciated that suchformed markings can be utilized in combination with any suitable markingdisclosed herein to denote one or more dimensions or sizes along thelength of the medical device.

In another embodiment, different heat activated pigments are utilized todenote different lengths and/or sizes of different medical devices. Forexample, a first medical device of a first length is heated at or abovea first color shifting temperature to cause a first pigment (in the baselayer applied to the first medical device) to change to a firstdesignated color. In this example, a second medical device of a second,different length is heated at or above a second color shiftingtemperature to cause a second pigment (in the base layer applied to thesecond medical device) to change to a second designated color.Accordingly, by utilizing different heat activated pigments, differentmedical devices of different lengths can be properly identified withoutincreasing or decreasing the diameter of the medical device, orsignificantly adversely affecting the function of the low-frictioncoating applied to such medical devices.

In one embodiment, a plurality of anti-microbial particles such assilver, ceramic, silver ceramic, silver oxide, glass silver or silvercompounds or any suitable anti-microbial agent are applied to one ormore of the surfaces of the coated medical wire to reduce and killbacteria and other potential germs that are located on the surface(s) ofthe coated medical wire or otherwise incorporated into the coatingformulation. In one embodiment, the anti-microbial particles areinterspersed with the uncured coating. During the curing process, someof the anti-microbial particles migrate or rise to the surface of thecoating in addition to the low-friction material. The ant microbialparticles are capable of killing bacteria and other harmful organismswhich contact the surface of the coated medical wire while in storage orwhile the medical device is deployed into the body. The coated medicalwire therefore minimizes or reduces the chance of infections or othercomplications in the body after the surgical procedure is complete.

In another embodiment, one or more of the pigments in the coating areformulated to change or shift colors a plurality of times. For example,a designated pigment in the coating is initially a green or blue colorthat will change or shift to a white or white/grey color with one levelof laser energy. In this example, the designated pigment will furtherchange or shift to a dark black color with another, higher or differentlaser energy. In one such embodiment, different types of laser energy,such as a CO₂ laser or a YAG laser, are utilized to create either darkor light color marks on the same coating. Accordingly, such pigments areformulated, depending on the different levels of applied laser energy,different laser types or different color shifting temperatures, toprovide a plurality of different color markings on a single medicaldevice.

In another embodiment, a suitable single coating including designatedresins and laser pigments from Tomatec Pigments is applied at athickness of 0.001 inches or 25 microns to an outer surface of themedical device. In this embodiment, after a laser energy is applied tothe coated medical device, the laser pigments in the coating react tochange color (with minimal ablation of the coating). For example, suchgray colored pigments, heat up and change to a black color with loweramounts of laser energy. In another example, such blue or green coloredpigments heat up and change to a white or gray color with lower amountsof laser energy.

In another embodiment, a radiopaque material, such as barium sulfide,barium sulfate or a suitable metal, such as tungsten, is added to thecoating. In this embodiment, a suitable marking is provided or shows upusing a suitable imaging device, such as an x-ray device, a magneticresonance imaging (MRI) device, or an ultrasound device. In one suchembodiment, the imaging device displays an image of the radiopaquemarking on one or more display devices of the imaging device. In anothersuch embodiment, the imaging device produces an image of the radiopaquemarking on a film or other suitable media, such as by producing an x-rayfilm. In these embodiments, the surgeon or other medical professionalutilize the imaging device to determine an exact location of the medicaldevice inside a patient and/or to determine one or more measurementsinside the patient.

In another embodiment, a base layer including a low-friction material,such as PTFE, is applied to a surface of the medical device. The medicaldevice and the applied base layer are then heated above a firstdesignated temperature to cure the coating. For example, as seen in FIG.14, a base layer of a low-friction material 282 is applied to the outersurface of the medical device.

After curing the medical device and the applied base layer, a radiopaquematerial is selectively bonded to spaced apart portions of the surfaceof the coated medical device. The coated medical device and the appliedradiopaque material are then heated above a second designatedtemperature to cure the radiopaque material. For example, as seen inFIG. 15, the radiopaque material is bonded to different, spaced apartareas of the medical device to form discrete bands 284 a, 284 b, 284 cand 284 d of the radiopaque material. In this example embodiment, asuitable amount or density of the radiopaque material is selectivelybonded to the surface of the coated medical device such that theradiopaque material is detectable when the medical device is viewedusing a suitable imaging device. Thus, the medical device of thisembodiment includes a plurality of discrete markings of a radiopaquematerial protruding from or situated above a low-friction coating.Accordingly, the resulting medical device will have different slightlyelevated bands or areas along the length of the medical device (such asto indicate distance), have low-friction characteristics (including lowfriction, low surface energy and/or non-stick characteristics) andinclude markings that show up using a suitable imaging device to providean exact location of the medical device inside a patient for safetyand/or measurement purposes.

In one embodiment, a clear or slightly pigmented low-frictiontop-coating is applied to the radiopaque coated medical device. Forexample, the clear or slightly pigmented applied low-friction top coatincludes one or more suitable fluoropolymers or low-friction particles,one or more particles of a hydrophilic material and a binder, such aspolyarylsulfone. In this embodiment, the clear or slightly pigmentedlow-friction top coat accounts for the valleys created between theslightly elevated radiopaque bands to provide that the medical deviceincludes a substantially smooth surface. For example, a clear orslightly pigmented low-friction top coated is applied to the radiopaquecoated medical device and the applied top coating is then suitably orpartially cured. In this example, the medical device is then passed thrua round die which removes any excess partially cured topcoat and leavesthe topcoat in the depressions caused by the slightly elevated bands ofradiopaque material as described above. In this example, the remainingtopcoat is then fully cured to provide a medical device with asubstantially smooth, low-friction surface.

In another embodiment, a radiopaque material is selectively bonded tospaced apart portions of a surface of the otherwise uncoated medicaldevice. In this embodiment, a suitable amount or density of theradiopaque material is selectively bonded to the surface of the medicaldevice such that the radiopaque material is detectable when the medicaldevice is viewed using a suitable imaging device. For example, as seenin FIG. 16, a radiopaque material is bonded to different spaced apartareas of the medical device to form discrete bands 284 a, 284 b, 284 cand 284 d of the radiopaque material.

After selectively bonding the radiopaque material to a surface of themedical device, the medical device (which includes the radiopaquematerial) is heated above a first designated temperature to cure theradiopaque material. After curing the medical device, a low-frictionmaterial, such as PTFE or other low-friction material, is applied to thesurfaces of the medical device (including over the selectively bondedareas of radiopaque material). The coated medical device and thelow-friction material are then heated above a second designatedtemperature to cure the coating of the low-friction material Forexample, as seen in FIG. 17, a low-friction material 282 is applied toan outer surface of the bonded radiopaque material and the remaininguncoated outer surfaces of the medical device. It should be appreciatedthat by first selectively applying the radiopaque material to a surfaceof the medical device and then applying the low-friction coating, theradiopaque material is covered with the low-friction material to providethat the entire surface of the medical device exhibits low-frictionproperties. Accordingly, the resulting medical device will havedifferent elevated areas or bands along the length of the medical device(such as to indicate distance), have low-friction characteristics(including low friction, low surface energy and/or non-stickcharacteristics) and include markings that show up using a suitableimaging device to provide an exact location of the medical device insidea patient for safety and/or measurement purposes.

In another embodiment, certain areas of the medical device are markedusing color shifting pigments (as described above) and radiopaquematerials are applied to certain other spaced apart areas of the medicaldevice. In one such embodiment, a suitable radiopaque material isapplied to a first portion of a medical wire that is inserted into apatient and a second portion of the medical wire that is not insertedinto the patient is marked using the above-described color shiftingpigments. For example, as seen in FIG. 18, a first segment 286 of themedical device includes a first area 288 which has been selected heatedand is a first color, a second area 290 which has not been selectivelyheated and is a default second color and a third area 292 which has beenselected heated and is a third color. In this example, the medicaldevice includes a second area 294 with discrete bands of a radiopaquematerial 282 and a low-friction material 284 applied to an outer surfaceof the radiopaque material and the remaining uncoated outer surfaces ofthe medical device. It should be appreciated that in this embodiment, asurgeon or other medical professional can utilize (1) the portion of themedical wire that is inserted into the patient and a suitable imagingdevice, and (2) the visibly marked portion of the medical wire notinserted inside the patient to determine the length of the medical wireinserted into a patient's body, the length of certain elements into apatient, and the exact location of certain elements inside a patient.

In different embodiments, the radiopaque material is applied to themedical device to form one or more patterns. Such patterns include, butare not limited to: one or more horizontal lines, bands or stripes, oneor more substantially horizontal lines, bands or stripes, one or morelongitudinal spiral shaped lines, bands or stripes. In such embodiments,the longitudinal spiral shaped markings enable a medical professional todetermine if the spiral shaped markings move and thus determine: (i) ifthe medical device is making progress advancing in the patient and (ii)if the medical device is rotating (in place) in the patient. It shouldbe appreciated that the radiopaque material may be applied to themedical device to create any suitable indicia or markings, such as oneor more: bands which indicate distance (as described above), parallellines, bands or stripes, perpendicular lines, bands or stripes,transverse lines, bands or stripes, axial lines, bands or stripes,longitudinal lines, bands or stripes, spiral patterned lines, bands orstripes, numbers, bar codes, and/or marks which indicate the size, type,material, part number, serial number, lot number, manufacturing date,instructions for use, manufacturer of the medical device, any indicia ormarking disclosed herein or any combination thereof.

In another embodiment, a plurality of anti-microbial particles such assilver, ceramic, silver ceramic, silver oxide, glass silver or silvercompounds or any suitable anti-microbial agent are included in thelow-friction coating and/or otherwise applied to one or more of thesurfaces of the coated medical device. In this embodiment, theanti-microbial particles reduce and kill bacteria and other potentialgerms or pathogens that are located on the surface(s) or come in contactwith the surface(s) of the coated medical device or otherwiseincorporated into the coating formulation. Accordingly, such a medicaldevice includes anti-microbial properties and one or more bands ofradiopaque material that may be viewed with a suitable imaging device.

In another embodiment, a clear or transparent top coat is applied to oneor more of the surfaces of the coated medical device after the visiblemarks are created in the base coating. In one embodiment, the topcoating is a low-friction or release coating or material, such asfluorinated materials, polytetrafluoroethylene, perfluoro-alkoxy,fluoroethylenepropylene, MFA, polyethylene, silicone, ceramiccomposites, paralyene silane polymers and other suitable low-frictioncoatings. Such a top coating provides that the markings described aboveare substantially covered or sealed underneath an additional layer skinof a low friction coating. It should be appreciated that this additionallayer is applied in a separate operation either after the color shiftmarks are created or after the marks are created in the base coat. Inanother embodiment, an ultraviolet cure (“uv cure”) low-friction, thinlayer of a special, clear, unpigmented, uv cure resin/fluoropolymer orresin/polyethylene material is formed over the marked medical deviceafter the base coating is applied, cured and post marked. This lowersthe friction of the surface since no heat is used to cure the uvmaterial and no change in the marked lower base coating takes placewhich may be employed for lower temperature base materials like plasticsor high friction reinforced plastics.

In another embodiment, a steel medical wire is treated with an iron,zinc, or manganese phosphate, which penetrates the steel surface andcoats the surface of the medical wire with a thin layer of thephosphate, which promotes the adhesion of a coating, improves corrosionresistance, and improves the chemical protection of the medical wire. Inanother embodiment, conversion coating or anodizing of an aluminummedical wire is employed to promote adhesion of a coating to the medicalwire and increase the surface hardness and corrosion resistance of themedical wire.

In another embodiment, at designated points on the medical device, thecolor shifting material is applied and the marks are created in agradation of successively, incrementally darker colors by usinggradually increasing or higher energy levels in directly adjacent areasto create a progressively darker and darker mark to further enhance theability of the device manufacturer to create distance codes or evendirectional force guides on the medical device. This gradation of colorshift method can be combined with cessation of energy input to create“breaks” in the color gradation to denote distance marks which are ofthe original color and are notably different from the gradation ofdarker markings.

In another embodiment, as seen in FIG. 19, a first or base low-frictioncoating 290 including a low-friction material, such as PTFE, is appliedto a surface of the medical device and suitably cured (or slightlyundercured) to 300° F. (1489° C.). For example, a layer approximatelyfifteen (15) microns thick of the first low-friction coating is appliedto a surface of the medical device. In different embodiments, the firstcoating is a Xylan® 1514 low-friction coating with the appropriatepigments, a VICOTE™ 700 Series coating with the appropriate pigments, aVICOTE™ 800 Series coating with the appropriate pigments, a DuPont™ 420Series coating with the appropriate pigments, a DuPont™ 257N504 coatingwith the appropriate pigments, a DuPont™ 851N504 coating with theappropriate pigments, a WHITFORD OC 600 Series coating with theappropriate pigments, a WHITFORD OC 8800 Series coating with theappropriate pigments, an MPC 992003 coating with the appropriatepigments, a Ultralon® OC Series coating with the appropriate pigments, aFluoroplate® 41141 Series coating with the appropriate pigmentsmanufactured by Orion Industries, or any suitable coating. In one suchembodiment, the first low-friction layer includes a first relativelylight colored pigment, such as titanium dioxide (i.e., a white coloredpigment). In one such embodiment, a radiopaque pigment, such as bariumsulfate is utilized in the first or base low-friction coating. In thisembodiment, the radiopaque pigment provides both a visually white ornear white colored PTFE coating and a slight radiopaque visibility whenused in a fluoroscope environment. In another embodiment, the first orbase low-friction coating includes one or more metal oxide pigments,and/or one or more FDA non-objection status for food contact approvedend use pigments.

As seen in FIG. 20, after applying the first low-friction layer, asecond low-friction coating 292, including a low-friction material, suchas PTFE, is applied to the coated surface of the medical device andsuitably cured to at least 700° F. (371.1° C.) to fuse the two coatingstogether. For example, a layer approximately five (5) microns thick ofthe second low-friction coating is applied to the previously coatedsurface of the medical device. In one embodiment, the secondlow-friction coating includes one or more pigments which contrast incolor and/or hue to one or more pigments in the first low-frictioncoating. In one such embodiment, the second low-friction layer includesa second relatively dark colored or hued pigment, such as a green, blackor blue colored pigment (which contrasts in color and/or hue to a firstrelatively light colored pigments in the first low-friction coating). Indifferent embodiments, the second coating is a Xylan 1514 low-frictioncoating with the appropriate pigments, a VICOTE™ 700 Series coating withthe appropriate pigments, a VICOTE™ 800 Series coating with theappropriate pigments, a DuPont™ 420 Series coating with the appropriatepigments, a DuPont™ 257N504 coating with the appropriate pigments, aDuPont™ 851N504 coating with the appropriate pigments, a WHITFORD OC 600Series coating with the appropriate pigments, a WHITFORD OC 8800 Seriescoating with the appropriate pigments, an MPC 992003 coating with theappropriate pigments, a Ultralon® OC Series coating with the appropriatepigments, a Fluoroplate® 41141 Series coating with the appropriatepigments manufactured by Orion Industries, or any suitable coating withpigments and a laser sensitive pigment to assist in ablation. In oneembodiment, the second low-friction coating includes one or more metaloxides pigments and/or one or more ceramic, or FDA approvednon-objection status for food contact end use pigments.

It should be appreciated that in different embodiments, the differentcoatings used for the first and second low-friction coatings depend, atleast in part, on the types of sterilization methods used to sterilizethe coated medical device disclosed herein. In one such embodiment, thefirst and/or second low-friction coatings are fully capable of beingsterilized using gamma radiation.

In this embodiment, after applying the two low-friction layers ofcontrasting colored coating, an amount of energy is selectively appliedto different spaced apart areas of the coated medical device. Forexample, a CO2 laser of 0.25 watts to 5.0 watts is selectively appliedto different, spaced apart areas of the coated medical device. Inanother example, a YAG laser using 10 watts of power, with 3000 speedand 500 frequency is used separately or sequentially on the coatedmedical device to provide different ablations of the second low-frictionlayer. It should be appreciated that the laser ablates or removes thesecond or outer low-friction layer while not significantly affecting thefirst low-friction layer. That is, the second low-friction layer withthe relatively dark colored pigment absorbs the applied energy (or partof the absorbed energy) and is accordingly vaporized or ablated from themedical device, while the first low-friction layer with a relativelylight colored pigment does not absorb the applied energy (or absorbsless of the applied energy) and is thus not affected by the appliedenergy. Thus, even after one low-friction layer has been removed, themedical device retains at least another low-friction layer to providelow friction properties along the length of the medical device.

As seen in FIG. 21, after the amount of energy, such as the laser isselectively applied to different spaced apart areas of the medicaldevice, the outer surfaces of the laser applied areas of the medicaldevice 294 a, 294 b and 294 c will include the first low-friction, lightcolored coating and the outer surfaces of the non-laser applied areas ofthe medical device 296 a, 296 b, 296 c and 296 d will include the secondlow-friction dark colored coating. It should be appreciated that since athin layer of the dark colored low-friction material is applied to themedical device, when that thin layer is removed from the medical device,any grooves or valleys in the surface of the low-friction coating willbe relatively shallow and not create any substantially sharp edgedshoulders which can scrape bodily tissues, snag vessels or arteries ofthe patient, or otherwise cause damage and/or trauma to the patient.Accordingly, in this embodiment, the medical device includes at leastone suitable low-friction coating applied to the outer surface of themedical device, wherein different areas of the medical device aresuitably marked with different colors. As described above, suchdifferent colored areas along the surface of the low-friction coatedmedical device indicate to surgeons or other medical professionals thelength of the medical device that is inserted into a patient.

In another embodiment, a band or stripe is created along the entire orselected lengths from the distal end to the proximal end of the medicaldevice. In one such embodiment, this stripe or band can be linear alongthe longitudinal axis of the medical device. For example, as seen inFIG. 22, portions of the second low-friction coating 292 are removedfrom the medical device to form a first designated pattern of the firstlow-friction coating 290, such as a horizontal line that is 2 mm wide.In another example (not shown), a plurality of portions of the secondlow-friction coating, such as two portions spaced 180 degrees apart fromeach other, are removed from the medical device to form a plurality ofhorizontal lines. In different embodiments, a laser is moved along thelength of the medical device, the medical device is moved relative tothe laser or any combination thereof to create such a horizontal orsubstantially horizontal line.

In another embodiment, the created horizontal stripe marking(s) areutilized in combination with circumferential bands of one or morespecified dimensions or sizes (as described above) along the length ofthe medical device to indicate distance. In this embodiment, thecombination of different markings provide surgeons or other medicalprofessionals suitable information regarding: (i) the length of themedical device that is inserted into a patient, (ii) if the medicaldevice is moving in the patient (as required by the medicalprofessional), and/or (iii) if the medical device is rotating in thepatient (as required by the medical professional). In one suchembodiment, the second low-friction coating is selectively ablated toform a linear stripe or band and one or more markings to indicatedistance. For example, as seen in FIG. 23, after the second low-frictioncoating has been selectively removed, the coated medical device includesa first designated pattern of the first low-friction coating 290 and aplurality of markings of the first low-friction coating 294 a to 294 dalong the length of the medical device.

In another such embodiment, the first and/or second low-frictioncoatings include a plurality of heat sensitive pigments as describedherein. In this embodiment, the second low-friction coating isselectively ablated to form a linear stripe or band and a plurality ofportions of the coated medical device are selectively heated (to shiftthe color of such heat sensitive pigments) to create a plurality ofmarkings to indicate distance. For example, as seen in FIG. 24, thesecond low-friction coating is selectively removed to create a firstdesignated pattern of the first low-friction coating 290 and a pluralityof markings 220 a to 220 d are created along the length of the medicaldevice by selective heating portions of the coating above a colorshifting temperature while simultaneously maintaining adjacent portionsof coating at a cooler temperature.

In another such embodiment, the created stripe or band can be a spiralshaped pattern along the length of the medical device. For example, asseen in FIG. 25, portions of the second low-friction coating 292 areremoved from the medical device to form a second designated pattern ofthe first low-friction coating 290, such as a 2 mm wide longitudinalspiral marking that continues in a spiral pattern for the length of themedical device. In different embodiments, the medical device is rotatedwhile the laser is moved along the length of the medical device, themedical device is rotated and simultaneously moved relative to the laseror any combination thereof. In such embodiments, the longitudinal spiralmarkings enable a medical professional to determine if the insertedmedical device is rotating in place and also to determine if the spiralmarkings move to determine if the medical device is making progress orotherwise advancing in the patient.

In another embodiment, the created longitudinal spiral shaped markingsare utilized in combination with circumferential bands of one or morespecified dimensions or sizes (as described above) along the length ofthe medical device to indicate distance. In this embodiment, thecombination of different markings provide surgeons or other medicalprofessionals suitable information regarding: (i) the length of themedical device that is inserted into a patient, (ii) if the medicaldevice is moving in the patient (as required by the medicalprofessional), and/or (iii) if the medical device is rotating in thepatient (as required by the medical professional). In one suchembodiment, the second low-friction coating is selectively ablated toform a longitudinal spiral stripe or band and one or more markings toindicate distance. For example, as seen in FIG. 26, after the secondlow-friction coating has been selectively removed, the coated medicaldevice includes a first longitudinal spiral pattern of the firstlow-friction coating 290 and a plurality of markings of the firstlow-friction coating 294 a to 294 d along the length of the medicaldevice.

In another such embodiment, the first and/or second low-frictioncoatings include a plurality of heat sensitive pigments as describedherein. In this embodiment, the second low-friction coating isselectively ablated to form a longitudinal spiral stripe or band and aplurality of portions of the coated medical device are selectivelyheated (to shift the color of such heat sensitive pigments) to create aplurality of markings to indicate distance. For example, as seen in FIG.27, the second low-friction coating is selectively removed to create adesignated longitudinal spiral pattern of the first low-friction coating290 and a plurality of markings 220 a to 220 d are created along thelength of the medical device by selective heating portions of thecoating above a color shifting temperature while simultaneouslymaintaining adjacent portions of coating at a cooler temperature.

It should be appreciated that in different embodiments, the outerlow-friction coating may be removed from the medical device to createcontrasting colors that provide any suitable indicia or markings, suchas one or more: bands, parallel lines, bands or stripes, perpendicularlines, bands or stripes, transverse lines, bands or stripes, axiallines, bands or stripes, longitudinal lines, bands or stripes, spiralpatterned lines, bands or stripes, numbers, bar codes, and/or markswhich indicate the size, type, material, part number, serial number, lotnumber, manufacturing date, instructions for use, manufacturer of themedical device, any indicia or marking disclosed herein or anycombination thereof.

In another embodiment, a clear or slightly pigmented low-frictiontop-coat, such as PTFE, particles of one or more suitable fluoropolymersor particles of a hydrophilic material, is applied to the laser ablatedmedical device. In this embodiment, the clear or slightly pigmentedlow-friction top coat accounts for the removed ablated areas of themedical device to provide a substantially smooth surface. That is, thelow-friction top coat fills in the relatively shallow valleys which arecreated by laser ablating the second low-friction coating to create amedical device with different colored portions and a substantiallycontinuous substantially smooth surface. For example, 5 microns of aclear or slightly pigmented low-friction top coat is applied to thelaser ablated medical device and the applied coating is then suitably orpartially cured. In one such embodiment, the medical device is thenpassed thru a round die which removes any excess partially cured topcoatand leaves the topcoat in the depressions that are caused by the laserablation as described above. The remaining topcoat is then fully curedto provide a medical device with different contrasting colors and asubstantially smooth, low-friction surface.

It should be appreciated that any suitable color or color combinationmay be utilized in association with the low-friction coated medicaldevice. In different embodiments, the available color choices of thedifferent low-friction coatings are all the prime colors, any suitablecombination of the prime colors, any color or color combination from thered, blue and yellow spectrums as well as any suitable black, white orgray color. For example, the color combinations include a white or otherlight color first low-friction or base coating and a green or bluecontrasting color second low-friction coating.

In another embodiment, the medical device disclosed herein includes arelatively dark colored first or base low-friction layer and arelatively light colored second low-friction layer. In one suchembodiment, the relatively dark first low-friction layer is suitablytreated to withstand the laser energy. In different embodiments, therelatively dark first low-friction layer is treated by using a suitable“alloy” material, such as aluminum or by using a suitable “leafing”material, such as mica. In this embodiment, such additions to the firstlow-friction layer protects the first low-friction layer from the laserenergy.

In another embodiment, a plurality of contrasting colored low-frictioncoatings are applied to a surface of the medical device. In thisembodiment, along one or more designated portions of the medical device,the outer coating is removed or ablated using a pattern of micro-dots,micro-marks or micro-ablations. Such ablation utilizing micro-dots ormicro-marks provides that the ablated portion of the medical deviceappears, without magnification, as the contrasting color or hue of theinner low-friction coating. It should be appreciated that utilizing suchmicro-dots, micro-marks or micro-ablations to ablate or remove the outerlow-friction coating further provides a tactile smooth outer layer eventhough micro-dot portions of the outer low-friction coating is removed.That is, the outer low-friction coating feels unbroken to the medicalprofessional (i.e., due to the ‘pillars’ of the outer coating whichremain) even though there is a color contrast between the micro-dotablated portions of the medical device and the non-micro-dot ablatedportions of the medical device.

In another embodiment, one or more color shifting pigments (as describedherein) are included in the first low-friction coating and/or the secondlow-friction coating. In this embodiment, in addition to ablating thesecond low-friction coating (along certain portions of the medicaldevice) to expose the contrasting color of the first low-frictioncoating, one or more portions of the medical device are selectivelyheated above a color shifting temperature to change the color of suchcolor shifting pigments. This embodiment thus provides a marked medicaldevice with a plurality of different colored sections.

In another embodiment, in addition to ablating the second low-frictioncoating (along certain portions of the medical device) to expose thecontrasting color of the first low-friction coating, other portions ofthe second low-friction coating are overheated with external heat tocreate another color on the marked medical device. For example, amedical device will have alternating green and white markings as aresult of the laser removal of the second or outer low-friction coatingas described above. In this example, a subsequent heat process using anon-laser energy source, such as infrared heat, hot air or directcontact with a heat source, will change the color of different areas ofthe second low-friction coating to a darker color while notsubstantially altering the low friction properties of this secondlow-friction coating. Such a resulting medical device includes a clearlyvisible green color with alternating white color markings around themedical device and one or more black or dark colored bands at specificareas along the medical device. Accordingly, this example coated medicaldevice will include a first white colored portion (i.e., the portionwhere the first low-friction coating is exposed), a second green coloredportion (i.e., the portion where the second low-friction coating isexposed) and a third black colored portion (i.e., the portion where thesecond low-friction coating is overheated). In one such embodiment, twotypes of lasers are utilized to provide a medical device with apartially ablated topcoat and a partially overheated topcoat. In anothersuch embodiment, one or more heat sensitive pigments (as describedherein) are included in the second low-friction coating to create acolor shift of the second low-friction coating when the secondlow-friction coating is heated above a suitable color shiftingtemperature. In another embodiment, a clear or partially pigmentedlow-friction top coat is applied to this medical device to provide asmooth surface.

In another embodiment, a plurality of anti-microbial particles such assilver, ceramic, silver ceramic, silver oxide, glass silver or silvercompounds or any suitable anti-microbial agent are included in the firstlow-friction coating, included in the second low-friction coating and/orotherwise applied to one or more of the surfaces of the coated medicaldevice. In this embodiment, the anti-microbial particles reduce and killbacteria and other potential germs that are located on the surface(s) ofthe coated medical device or otherwise incorporated into the coatingformulation.

In another embodiment, a radiopaque material, such as barium sulfide,barium sulfate or a suitable metal, such as tungsten, is included in thefirst low-friction coating, included in the second low-friction coatingand/or otherwise applied to one or more of the surfaces of the coatedmedical device. In this embodiment, the radiopaque material providesthat a suitable marking shows up when using a suitable imaging device.In these embodiments, the surgeon or other medical professional utilizethe imaging device to determine an exact location of the medical deviceinside a patient and/or to determine one or more measurements inside thepatient.

In another embodiment, a plurality of low-friction coatings are appliedto the medical device. In this embodiment, one or more of thelow-friction coating are subsequently removed to denote differentmarkings along the medical device. In one such embodiment, threedifferent colored low-friction coatings are applied to the medicaldevice wherein different coatings are selectively removed at differentportions of the medical device to denote different information to themedical professional. For example, three different colored low-frictionlayers can be utilized wherein a suitable amount of laser energy removesthe top two low-friction layers and retains the bottom low-frictionlayer to denote a mid-point of a medical device (or to denote othersuitable markings). In another example, three different coloredlow-friction layers can be utilized wherein a suitable amount of laserenergy (and/or a different type of energy) removes all threelow-friction layers to leave the bare metal substrate exposed to denotea mid-point of a medical device (or to denote other suitable markings).In these example, different types of laser energy may be used, such as aCO₂ laser and a separate YAG laser, for the selective removal ofdifferent ones of the low-friction layers.

In another embodiment, a single low-friction coating is applied to themedical device. In this embodiment, different portions of the appliedlow-friction coating are removed or ablated (using laser energy or othersuitable energy) to leave the bare metal substrate exposed. In differentembodiments, the low-friction coating may be removed from the medicaldevice to create contrasting colors (between the low-friction coatingand the bare metal substrate) that provide any suitable indicia ormarkings, such as one or more: bands, parallel lines, bands or stripes,perpendicular lines, bands or stripes, transverse lines, bands orstripes, axial lines, bands or stripes, longitudinal lines, bands orstripes, spiral patterned lines, bands or stripes, numbers, bar codes,and/or marks which indicate the size, type, material, part number,serial number, lot number, manufacturing date, instructions for use,manufacturer of the medical device, any indicia or marking disclosedherein or any combination thereof.

In another embodiment, as seen in FIG. 28, a first or base low-frictioncoating or layer 300 including a low-friction material, such as PTFE, isapplied to a surface of the medical device and suitably cured (orslightly under cured) to 300° F. (148.9° C.). For example, a layerapproximately 8 to 25 microns thick of the first low-friction coating isapplied to a surface of the medical device. In different embodiments,the first coating is a Xylan® 1514 low-friction coating with theappropriate pigments, a VICOTE™ 700 Series coating with the appropriatepigments, a VICOTE™ 800 Series coating with the appropriate pigments, aDuPont™ 857N504 coating with the appropriate pigments, a DuPont™ 857N010coating with the appropriate pigments, a DuPont™ 851N204 coating withthe appropriate pigments, a DuPont™ 851N504 coating with the appropriatepigments, a DuPont™ 851N604 coating with the appropriate pigments, aWHITFORD OC 600 Series coating with the appropriate pigments, a WHITFORDOC 625 Series coating with the appropriate pigments, a WHITFORD OC 655Series coating with the appropriate pigments, a WHITFORD OC 8800 Seriescoating with the appropriate pigments, a MANSFIELD PROTECTIVE PRODUCTSMPC 992003 coating with the appropriate pigments, a UltraIon® OC Seriescoating with the appropriate pigments, a Fluoroplate® 41141 Seriescoating manufactured by Orion Industries, Ltd., with the appropriatepigments or any suitable coating with pigments and a laser sensitivepigment to assist in ablation.

In one such embodiment, the first low-friction layer includes a firstcolored pigment, such as a relatively light colored pigment such astitanium dioxide (i.e., a white colored pigment). In one suchembodiment, a radiopaque pigment, such as barium sulfate is utilized inthe first or base low friction coating. In this embodiment, theradiopaque pigment provides both a visually white or near white coloredPTFE coating and a slight radiopaque visibility when used in afluoroscope environment. In another embodiment, the first or baselow-friction coating includes one or more metal oxide pigments, and/orone or more FDA non-objection status for food contact approved end usepigments. In another embodiment, a plurality of different colored firstlow-friction coatings are applied to different portions of the medicaldevice.

As seen in FIG. 29, after applying the first low-friction layer, anamount of energy is selectively applied to different spaced apart areasof the coated medical device. For example, a 002 laser of 0.25 watts to5.0 watts is selectively applied to different, spaced apart areas of thecoated medical device. In another example, a YAG laser using 10 watts ofpower, with 3000 speed and 500 frequency is used separately orsequentially on the coated medical device to provide different ablationsof the first low-friction layer. It should be appreciated that the laserablates or removes the first low-friction layer to expose the bare metalsubstrate of the medical device.

Such removal of the first low-friction coating provides one or moresuitable markings of the medical device (i.e., a contrast appearsbetween the first colored low-friction coating and the shiny stainlessmetal of the exposed substrate of the medical device.) and since only arelatively small amount of the first low-friction coating is removed,the laser ablated medical device retains the majority of the surfaceslow-friction properties. It should be appreciated that the firstlow-friction coating can be selectively removed from the surface of themedical device in any suitable pattern or configuration. That is, one ormore areas of the applied first low-friction can be removed to exposethe bare metal substrate of the medical device as one or more: bands,parallel lines, bands or stripes, perpendicular lines, bands or stripes,transverse lines, bands or stripes, axial lines, bands or stripes,longitudinal lines, bands or stripes, spiral patterned lines, bands orstripes, numbers, letters, bar codes, and/or marks which indicate thesize, type, material, part number, serial number, lot number,manufacturing date, instructions for use, manufacturer of the medicaldevice, any indicia or marking disclosed herein or any combinationthereof.

As seen in FIG. 30, after the amount of energy is selectively applied todifferent spaced apart areas of the medical device to remove the firstlow-friction coating, a second low-friction coating or layer 302including a low-friction material, such as PTFE, is applied to part orall of such spaced apart areas of the medical device. Such appliedsecond low-friction layer fills part or all of the spaced apart areas orvalleys which are created by laser ablating the first low-frictioncoating. After filling in part or all of such areas with the secondcoating, the second coating is then suitably cured up to a maximumtemperature of 700° F. (371.1° C.) to fuse the side edges of the twocoatings together. For example, a layer approximately 8 to 20 micronsthick of the second low-friction coating is applied to the spaced apartareas that previously exposed the bare metal substrate of the medicaldevice.

In one embodiment, the second low-friction coating is applied using oneor more electrophoretic type or brush-plating methods. In this method,the partially laser ablated medical device is immersed in secondlow-friction coating of a high-water content electrophoretic paintemulsion. Following this immersion, an electric current is passedthrough both the medical device and the emulsion. As the surface of themedical device with the remaining first low-friction coating repelswater based coatings the high-water content electrophoretic paintemulsion of the second coating), once the electric current is passedthrough both the medical device and the second coating, the chargedsecond coating will be attracted to and adhere to the exposed metal ofthe medical device. After the second low-friction coating adheres to theexposed metal of the medical device, the excess electrophoreticallyapplied coating is removed by rinsing (or other appropriate removalmethods) and the medical device is cured at less than 700° F. (371.1°C.).

In one embodiment, the second low-friction coating includes one or morepigments which contrast in color and/or hue to one or more pigments inthe first low-friction coating. In one such embodiment, the secondlow-friction layer includes a second relatively dark colored or huedpigment, such as a green, black or blue colored pigment (which contrastsin color and/or hue to a first relatively light colored pigments in thefirst low-friction coating). In one embodiment, the second coating is aMANSFIELD PROTECTIVE PRODUCTS MPC 992003 coating (or other similarformulation) with the appropriate pigments. In another embodiment, thesecond coating is a CLEARCLAD COATINGS 252A472 eletrophoreticallow-friction coating (or other similar formulation) with the appropriatepigments. In another embodiment, the second coating is a Xylan® 1514low-friction coating with the appropriate pigments, a VICOTE™ 700 Seriescoating with the appropriate pigments, a VICOTE™ 800 Series coating withthe appropriate pigments, a DuPont™ 420 Series coating with theappropriate pigments, a DuPont™ 257N504 coating with the appropriatepigments, a DuPont™ 851N504 coating with the appropriate pigments, aWHITFORD OC 600 Series coating with the appropriate pigments, a WHITFORDOC 8800 Series coating with the appropriate pigments, a Ultralon® OCSeries coating with the appropriate pigments, a Fluoroplate® 41141Series coating manufactured by Orion Industries, Ltd., with theappropriate pigments or any suitable coating. In one embodiment, thesecond low-friction coating includes one or more metal oxides pigmentsand/or one or more ceramic, or FDA approved non-objection status forfood contact end use pigments.

Accordingly, this embodiment provides that the outer surfaces of thenon-laser applied areas of the medical device 304 a, 304 b, 304 c and304 d will include the first low-friction, first colored coating and theouter surfaces of the laser applied areas of the medical device 306 a,306 b and 306 c will include the second low-friction, second,contrasting colored coating. Such a medical device includes asubstantially continuous substantially smooth surface. Thus, in thisembodiment, the filling of any areas which the first low-friction layerwas removed will minimize sharp edged shoulders which can scrape bodilytissues, snag vessels or arteries of the patient, or otherwise causedamage and/or trauma to virtually any part of the patient's body.Accordingly, in this embodiment, different areas of the coated medicaldevice are suitably marked with different colors and the medical deviceincludes at least one suitable low-friction coating applied to the outersurface of the medical device such that the low-friction surface isalways in contact with the counter face or the tissue of the patient. Asdescribed above, such different colored areas along the surface of thelow surface energy, low-friction coated medical device provide a coatedmedical device (without any unintentionally exposed metal portions)configured to indicate to surgeons or other medical professionals thelength of the medical device that is inserted into a patient.

Moreover, as the first low-friction coating can be selectively removedfrom the surface of the medical device in any suitable pattern orconfiguration and the second low-friction coating can fill part or allof the areas left by such removal, the second low-friction coating canbe selectively applied to the surface of the medical device in anysuitable pattern or configuration. That is, the second low-friction canbe applied to the surface of the medical device as one or more: bands,parallel lines, bands or stripes, perpendicular lines, bands or stripes,transverse lines, bands or stripes, axial lines, bands or stripes,longitudinal lines, bands or stripes, spiral patterned lines, bands orstripes, letters, numbers, bar codes, alpha numeric marks, and/or markswhich indicate the size, type, material, part number, serial number, lotnumber, manufacturing date, instructions for use, manufacturer of themedical device, any indicia or marking disclosed herein or anycombination thereof.

In another embodiment, a clear or transparent top coat is applied to oneor more of the surfaces of the coated medical device after the secondlow-friction coating has been selectively applied to the exposedsurfaces of the medical device. In one embodiment, the top coating is alow-friction or release coating or material, such as fluorinatedmaterials, polytetrafluoroethylene, perfluoro-alkoxy,fluoroethylenepropylene, MFA, polyethylene, silicone, a resin like clearmedical grade epoxy in liquid or power form, ceramic composites,paralyene silane polymers and other suitable low-friction coatings. Sucha top coating provides that the markings described above aresubstantially covered or sealed underneath an additional layer skin of alow friction coating.

In another embodiment, a plurality low-friction coatings are applied tothe medical device. In this embodiment, for at least one portion of themedical device, the applied low-friction coatings are removed or ablated(using laser energy or other suitable energy) to leave the bare metalsubstrate exposed. In different embodiments, one, more or each thelow-friction coatings may be removed from the medical device to createcontrasting colors (between one of the low-friction coatings and thebare metal substrate or between two contrasting colored low-frictioncoatings) that provide any suitable indicia or markings, such as one ormore: bands, parallel lines, bands or stripes, perpendicular lines,bands or stripes, transverse lines; bands or stripes, axial lines, bandsor stripes, longitudinal lines, bands or stripes, spiral patternedlines, bands or stripes, numbers, bar codes, and/or marks which indicatethe size, type, material, part number, serial number, lot number,manufacturing date, instructions for use, manufacturer of the medicaldevice, any indicia or marking disclosed herein or any combinationthereof.

In another embodiment, after one or more low-friction coatings have beenremoved, a vibratory bath with appropriate particles and fluids isutilized to slightly polish the coated outer surfaces of the medicaldevice. In this embodiment, the vibratory bath selectively radiuses orpolishes the diameter of the coated medical device to result in asmoother transition from the exposed first low-friction coating to thesecond low-friction coating. In one such embodiment, the particlescontained within the vibratory bath are a plastic/ceramic abrasive togently abrade the edges of the protruding bands of the coating. Theseparticles are wetted continuously with appropriate fluids that containvarious agents to assist in dispersing the dislodged low-frictionparticles that have been removed during the vibratory process. In onesuch embodiment, the processed medical device is then ultrasonicallydegreased in an aqueous solution to remove any remaining particles.

In another embodiment, as seen in FIG. 31, before applying a coating tothe surface of the medical device, the medical device is prepared forcoating as described above and as indicated in block 310. Afterpreparing the medical device for coating, a first or base low-frictioncoating or layer including a low-friction material, such as FIFE or anysuitable low-friction material described herein, is applied to thesurface of the medical device as indicated in block 312. In oneembodiment, the first low-friction coating includes a first coloredpigment, such as a relatively dark colored pigment (e.g., a blue, black,purple or green colored pigment). In another embodiment, the firstlow-friction coating includes a first colored pigment, such as arelatively light colored pigment (e.g., a white, yellow or orangecolored pigment). This first low-friction layer is applied to themedical device using any suitable application technique described above.After applying the first low-friction layer to the surface of themedical device, the applied first low-friction layer is suitably curedor under cured as indicated in block 314.

After applying and curing or under curing the first low-friction layer,a first end of the medical device is secured (i.e., held stationary orotherwise held in place), a second, free end of the medical device isturned a designated number of rotations or turns upon its longitudinalaxis and the second end of the medical device is then secured (i.e., tokeep the medical device stretched and twisted) as indicated in block316. In one such embodiment, the first end of the medical device isconnected to a suitable holder or clamp, and the second, free end of themedical device is initially twisted or turned (clockwise orcounterclockwise by a suitable twisting device) a designated number oftimes, such as ten to one-hundred-forty complete turns and thenconnected to a suitable holder or clamp. It should be appreciated thatthe designated number of rotations or turns of the free, second end ofthe medical device is determined based on how tight of a spiral pattern(i.e., the desired frequency and pitch of the spiral pattern) is desiredon the medical device and the length of the medical device. That is, thegreater the number of rotations or turns of the free, second end of themedical device, the tighter the spiral pattern along the length of themedical device (i.e., the less distance between the centers of theadjacent spiral marks). In other words, the designated quantity of turnsis based on one or more of the construction of the medical device, thematerial of the medical device, the length of the medical device, thediameter of the medical device, and/or the tension of the medicaldevice.

After turning the medical device a number of times upon its longitudinalaxis, one or more parts of the medical device not desired to be furthercoated are blocked or shielded as indicated in block 318. As describedbelow, such blocking, protecting, shielding or otherwise suitablymasking of one or more parts of the medical device provide that certainparts or portions of the medical device are further coated and certainother parts or portions of the medical device are not further coated.

After blocking or shielding one or more unblocked parts or portions ofthe medical device, a second, low-friction coating or layer including alow-friction material, such as PTFE or any suitable low-frictionmaterial described herein, is applied to a lengthwise or partiallengthwise portion of the coated surface of the medical device asindicated in block 320. In this embodiment, the application of thesecond low-friction coating to certain unblocked, unprotected,unshielded or otherwise unmasked parts or portions of the medical device(coupled with the second low-friction coating not being applied tocertain blocked, protected, shielded or otherwise masked parts orportions of the medical device) provides that the second coating isselectively applied to the coated surface of the medical device. In onesuch embodiment, the second low-friction coating is selectively appliedalong a longitudinal portion of the coated surface to form a linearstrip or band along the length of the coated surface of the twistedmedical device. For example, along the length of the medical device, athin stripe of the second low-friction coating is applied, such as byspraying, rolling or roller coating, onto a top longitudinally extendingportion of the coated surface of the twisted medical device. In oneembodiment in which the first low-friction coating includes a firstrelatively dark colored pigment, the second low-friction coatingincludes a second contrasting colored pigment, such as a relativelylight colored pigment (e.g., a white colored pigment). In anotherembodiment in which the first low-friction coating includes a firstrelatively light colored pigment, the second low-friction coatingincludes a second contrasting colored pigment, such as a relatively darkcolored pigment (e.g., a white colored pigment).

After applying the second low-friction coating to one or more desiredportions of the twisted medical device (i.e., one or more unblocked orshielded parts of the twisted medical device), the first end and thesecond end of the medical device are released (to enable the twistedmedical device to unwind to a relaxed or normal state) as indicated inblock 322. The coated medical device is then suitably cured to bond thetwo low-friction layers together as indicated in block 324.

The resulting medical wire includes a spiral shaped pattern along thelength of the medical device. That is, the linear strip or band of thesecond low-friction coating that was applied when the medical device wastwisted becomes a spiral shaped strip or band of the second low-frictioncoating when the same medical device is untwisted. Such a medical devicewith longitudinal spiral markings enables a medical professional todetermine if the inserted medical device is moving as desired by themedical professional. Such a medical device with longitudinal spiralmarkings further enables a medical professional to determine if theirintended imparted motion of the medical device resulted in causing themedical device to advance, retract rotate, be withdrawn or otherwisemove in the patient by determining if the spiral markings appear tomove. For example, the illusion of movement of the spiral markings ofthe medical device enable a medical professional to determine if themedical professional's gloved fingers are actually providing the tactileforces to move the medical device as intended. Moreover, such a medicaldevice includes a substantially continuous substantially smooth surface.Thus, in this embodiment, the different areas of the coated medicaldevice are suitably marked with different colors and the medical deviceincludes at least one suitable low-friction coating applied to the outersurface of the medical device such that the low-friction surface isalways in contact with the counter face or the tissue of the patient. Asdescribed above, such different colored areas along the surface of thelow surface energy, low-friction coated medical device (i.e., a firstlongitudinal half of the medical device includes a first colored basecoat and a second longitudinal half of the medical device includes asecond, different colored base coat) provide a coated medical deviceconfigured to indicate to surgeons or other medical professionals thelength of the medical device that is inserted into a patient.

In one example embodiment, as seen in FIGS. 32A and 32B, the medicaldevice is a medical guide wire 330 including one or more elongatedstrands of medical wire helically wound or coiled such that adjacentturns of the wire are in contact with each other (i.e., the resultingmedical guide wire is generally shaped like a coiled spring). In thisexample embodiment, the medical guide wire has a first or proximal end332, a second or distal end 334 and an outer surface 336.

As seen in FIGS. 33A and 33B, a first or base low-friction coating 338including a low-friction material, such as PTFE, is applied to the outersurface of the illustrated medical guide wire 336 and slightly undercured to between 300° F. (148.9° C.) and 400° F. (204.4° C.). Forexample, a layer approximately 0.0003 inches to 0.0004 inches thick ofthe first low-friction coating is applied to an outer surface of themedical guide wire. In different embodiments, the first coating is aXylan 1514 low-friction coating with the appropriate pigments, a VICOTE™700 Series coating with the appropriate pigments, a VICOTE™ 800 Seriescoating with the appropriate pigments, a DuPont™ 420 Series coating withthe appropriate pigments, a DuPont™ 257N504 coating with the appropriatepigments, a DuPont™ 851N204 coating with the appropriate pigments, aDuPont™ 851N504 coating with the appropriate pigments, a DuPont™ 851N₆₀₄coating with the appropriate pigments, a WHITFORD OC 600 Series coatingwith the appropriate pigments, a WHITFORD OC 625 Series coating with theappropriate pigments, a WHITFORD OC 655 Series coating with theappropriate pigments, a WHITFORD OC 8800 Series coating with theappropriate pigments, a MANSFIELD PROTECTIVE PRODUCTS MPC 992003 coatingwith the appropriate pigments, a Ultralon® OC Series coating with theappropriate pigments, a Fluoroplate® 41141 Series coating manufacturedby Orion Industries, Ltd., with the appropriate pigments or any suitablecoating.

In one such embodiment, the first low-friction layer includes a firstrelatively dark colored pigment (i.e., a green, black, purple or bluecolored pigment). In one such embodiment, the first low-friction layerincludes a first relatively light colored pigment (i.e., a white coloredpigment), such as titanium dioxide. In one such embodiment, a radiopaquepigment, such as barium sulfate is utilized in the first or baselow-friction coating. In another embodiment, the first or baselow-friction coating includes one or more metal oxide pigments, and/orone or more FDA non-objection status for food contact approved end usepigments. In another embodiment, a plurality of different colored firstlow-friction coatings are applied to different portions of the medicaldevice.

As seen in FIGS. 34A and 34B, after applying the first low-frictionlayer (or after obtaining a precoated medical guide wire), the first endof the medical guide wire 332 is secured (i.e., held stationary or heldin place by a suitable holding device or clamp 340 a) and the second,free end of the medical guide wire 334 is twisted or wound a designatednumber of rotations or turns upon its longitudinal axis 348 (orsubstantially upon its longitudinal axis). As mentioned above, thedesignated number of rotations or turns of the free, second end of themedical guide wire is determined based on how tight of a spiral patternis desired on the medical guide wire and the length of the medical guidewire.

In one such embodiment, as seen in FIG. 34B, the second, free end of themedical guide wire is turned in the same direction that the elongatedstrands of the medical guide wire are helically wound (i.e., it istightened). In this direction, as the second free end of the medicalguide wire is turned, the diameter of the medical guide wire constricts.In another such embodiment, the second, free end of the medical guidewire is turned in the opposite direction that the elongated strands ofthe medical guide wire are helically wound (i.e., it is loosened). Inthis direction, as the second free end of the medical guide wire isturned, the diameter of the medical guide wire expands.

In one embodiment (not shown), one or more medical guide wires are laidflat on a table, such as a magnetic table, and the first end of eachmedical guide wire is attached to the table, such as taped down (orotherwise prevented from rotating). In this embodiment, the second endof each medical guide wire is rotated to tighten up the helically woundelongated strands, wherein the number of turns determines the pattern ofthe spiral marking. In this embodiment, after the designated quantity ofturns of the medical guide wire to twist the coiled medical guide wire,the second end (i.e., the twisted end) of the medical guide wire isattached to the table to keep the medical guide wire stretched with noextra pull or stretching of the medical guide wire. R should beappreciated that in this embodiment, the magnetic table will assist inkeeping any magnetic stainless alloy medical guide wires, such as a 304valloy, flat during a subsequent selective application of secondlow-friction coating as described below.

In this example embodiment, after turning the medical guide wire anumber of times upon its longitudinal axis and then securing the secondend of the medical guide wire, one or more parts of the medical guidewire not desired to be further coated are protected, shielded or masked.Such protecting of certain parts of the medical guide wire provides thatno further coating is applied to such protected parts.

In one such embodiment (not shown), to protect or mask one or more partsof the medical guide wire, a shielding device is utilized that includestwo masking members, such as two metal members or plastic members, thatare a designated length apart, such as 0.03 inches apart. The gapbetween the two masking members of the shielding device extends for adistance that corresponds to part or all of the length of the twistedmedical guide wire. In this embodiment, the shielding device is placedabove the twisted medical guide wire such that the gap between the twomasking members of the shielding device corresponds to part or all ofthe length of the twisted medical guide wire. Accordingly, thisembodiment provides that the portions of the twisted medical guide wirethat do not correspond to the gap between the two masking members of theshielding device are protected or masked (and the portion of the twistedmedical guide wire that corresponds to the gap between the two maskingmembers of the shielding device are not protected or masked).

In one such embodiment (not shown), shielding device above the wire issuitably be slotted or notched in a dimensional pattern to denotedistance from each adjacent mark or another pattern to denote mm fromone end with 5 mm marks. This is a pattern where the 10 mm mark is 3 mmwide and the 5 mm are 1 mm wide but that requires counting. For example,a measured strip of a second coating is applied along a longitudinallyextending portion of an untwisted medical guide wire, the medical guidewire is then twisted 180 degrees and this process is repeated a secondtime such that the two longitudinally extending stripes (withappropriate measurement spaces in the strip) could show rotation,movement, measurement of insertion and movement of a catheter that isplaced over the medical guide wire. Such use of this pattern enablesprecise placement of a catheter over the medical guide wire and themovement of the catheter a precise, easily determined amount.

In another embodiment (not shown), to protect or mask one or more partsof the medical guide wire, two masking members, such as two metalmembers or plastic members, that are each the same thickness of thetwisted medical guide wire, are placed on each side of the twistedmedical guide wire. Accordingly, this embodiment provides that theportions of the twisted medical guide wire that are not exposed betweenthe two masking members are protected or masked (and the portion of thetwisted medical guide wire that are exposed between the two maskingmembers are not protected or masked).

As seen in FIGS. 35A and 35B, after turning the medical guide wire anumber of times upon its longitudinal axis, then securing the second end334 of the medical guide wire (using a suitable holding device or clamp340 b) and protecting, shielding, blocking or otherwise masking one ormore parts of the medical guide wire not desired to be further coated(not shown), a second, low-friction coating 342 including a low-frictionmaterial is applied along to a longitudinally extending portion part orall of the unprotected or unmasked length of the coated surface of themedical guide wire. In one such embodiment, the second low-frictioncoating is applied along an unprotected or unmasked longitudinallyextending portion of the coated surface to form a linear strip or bandalong the length of the coated surface of the twisted medical guidewire. In another such embodiment, the second low-friction coating isapplied along an unprotected or unmasked longitudinally extendingportion of the coated surface to form a linear strip or band along part,but not all of, the length of the coated surface of the twisted medicalguide wire. For example, a visible layer approximately 4 to 8 micronsthick of the second low-friction coating is applied to a toplongitudinal portion of the twisted medical guide wire. It should beappreciated that any suitable manner disclosed herein of selectivelyapplying the coating to the twisted medical device may be utilized inassociation with the present disclosure.

In the above-described embodiment which utilizes a shielding device thatincludes two masking members, after placing the shielding device overthe twisted medical guide wire, the second low-friction coating issprayed down through the gap between the two masking members and ontothe twisted medical guide wire. In this embodiment, as the two maskingmembers protect or mask the portions of the twisted medical guide wireexcept for the longitudinal portion of the twisted medical guide wireexposed through the gap between the two masked members and the secondlow-friction coating is only applied through such a gap, the secondlow-friction coating is only applied to an unprotected top longitudinalportion of the twisted medical guide wire.

In the above-described embodiment which utilizes two masking membersthat are placed at each side of the twisted medical guide wire, thesecond low-friction coating is applied (i.e., sprayed or rolled onto) tothe portion of the twisted medical guide wire that is exposed betweenthe two masking members. In this embodiment, as the two masking membersprotect or mask the portions of the twisted medical guide wire exceptfor the longitudinal portion of the twisted medical guide wire exposedbetween the two masked members and the second low-friction coating isonly applied between such masked members, the second low-frictioncoating is only applied to an unprotected top longitudinal portion ofthe twisted medical guide wire. For example, this configuration providesthat a longitudinal stripe of the second low-friction coating (with awidth between 0.002 and 0.03 inches) is applied to the twisted medicalguide wire.

In one embodiment, the second low-friction coating includes one or morepigments which contrast in color and/or hue to one or more pigments inthe first low-friction coating. In another embodiment, the secondcoating is a Xylan® 1514 low-friction coating with the appropriatepigments, a VlCOTE™ 700 Series coating with the appropriate pigments, aVICOTE™ 800 Series coating with the appropriate pigments, a DuPont™257N504 coating with the appropriate pigments, a DuPont™ 851N204 coatingwith the appropriate pigments, a DuPont™ 851N504 coating with theappropriate pigments, a DuPont 851N604 coating with the appropriatepigments, a WHITFORD OC 600 Series coating with the appropriatepigments, a WHITFORD OC 625 Series coating with the appropriatepigments, a WHITFORD OC 655 Series coating with the appropriatepigments, a WHITFORD OC 8800 Series coating with the appropriatepigments, a MANSFIELD PROTECTIVE PRODUCTS MPC 992003 coating with theappropriate pigments, a Ultralon® OC Series coating with the appropriatepigments, a Fluoroplate 41141 Series coating manufactured by OrionIndustries, Ltd., with the appropriate pigments or any suitable coating.In one embodiment, the second low-friction coating includes one or moremetal oxides pigments and/or one or more ceramic, or FDA acceptablenon-objection status for food contact end use pigments.

It should be appreciated that in different embodiments, the firstlow-friction coating and/or the second low friction coating mayalternatively include or also include one or more of the followingmaterials: PTFE, PFA, FEP, PE, PEEK, PEK, amide imide, imide,polyethersulfone (PES), polyimide amide (PAD, polyaranylsulfone,polyphenelyhenesupsfide (PPS), epoxy, silicone, phenolic, phenoxy,polyimide, polyamide, polyamide-amide, polyphenylene sulfide,polyarylsulfone, polyethylene, fluorinated ethylene propylene,perfluoroalkoxy, any suitable binder or resin, any suitable organicpigment (e.g., phthalocyanine blues and greens, diarylide yellows andoranges, quanacridone, naphthol and toluidine reds, carbizole violets,and carbon black), any suitable inorganic pigment (e.g., iron oxide redsand yellows, chrome oxide greens, titanium oxide white, cadmium reds,ultramarine blues, moly oranges, lead chromate yellows, and mixed metaloxides of various shades of brown, yellow, blue, green and black), anysuitable extender pigment (e.g., talc, calcium carbonate, silicate andsulfate, silica, mica, aluminum hydrate and silicate, and barium sulfate(blanc fixe/barites)), any suitable magnetic receptive pigment, anysuitable laser excitable pigments (e.g., near-infrared reflectivepigements include, but are not limited to, mica, pearl pigment, Kaolinand aluminum silicate derivatives, antomony trioxide, metallic pigment,aluminum flake pigment, and iron oxide), and/or any suitable functionalpigments (e.g., conductive pigments, flattening pigments for controllinggloss, clays and other rheology modifying pigments).

In one embodiment wherein the first low-friction coating includes arelatively dark colored pigment, the second low-friction layer includesa second relatively light colored or hued pigment (which contrasts incolor and/or hue to a first relatively dark colored pigments in thefirst low-friction coating). In one such embodiment, the secondlow-friction layer includes a second relatively light colored pigment(i.e., a white colored pigment), such as titanium dioxide. In anothersuch embodiment, a radiopaque pigment, such as barium sulfate isutilized in the second low-friction coating. In another embodimentwherein the first low-friction coating includes a relatively lightcolored pigment, the first low-friction layer includes a secondrelatively dark colored pigment (i.e., a green, black, purple or bluecolored pigment).

After applying the second low-friction coating to one or more desiredportions of the twisted medical guide wire (i.e., one or more unblockedor shielded parts of the twisted medical guide wire), the medical guidewire is dried or semi-cured so that the second coating is sufficientlydry and physically stable. Both ends of the twisted medical guide wireare released to enable the medical guide wire to untwist around itslongitudinal axis 348 (or substantially around its longitudinal axis)and return to its pre-twisted state. The coated medical guide wire isthen suitably final cured at no more than 700° F. (371.1° C.) so thatboth coatings are bonded to each other and bonded to the surface of themedical guide wire. After such curing, as seen in FIGS. 36 and 37, theresulting medical guide wire includes a spiral shaped pattern (aroundthe circumference of the medical device) that extends along the lengthof the medical guide wire. Accordingly, this embodiment provides thatcertain non-spiral shaped outer surfaces of the medical guide wire(areas 344 a and 344 b of FIG. 36 and areas 344 a, 344 b, 344 c and 344d of FIG. 37) will include the first low-friction, dark colored coatingand certain spiral shaped outer surfaces of the medical guide wire(areas 346 a, 346 b and 346 c of FIG. 36 and areas 346 a, 346 b, 346 cand 346 d of FIG. 37) will include the second, low-friction lightcolored coating. For example, as seen in FIGS. 36 and 37, portions ofthe second low-friction coating 342 are added when the medical guidewire is twisted to form a designated pattern of the second low-frictioncoating, such as a 1 mm wide longitudinal spiral marking that continuesin a spiral pattern for the length of the medical guide wire.

As described above, the twisting of the medical guide wire and theapplication of the linear strip or band of the second low-frictioncoating to the twisted medical guide wire provides that when the samemedical device is untwisted and returns to the original configuration,the linear strip or band of the second low-friction coating becomes alongitudinally extending spiral shaped strip or band along the outersurface of the medical guide wire. This process of forming a spiralshaped pattern along the length of a medical guide wire is illustratedin FIGS. 38A to 38E. Specifically, FIG. 38A displays a point in timeafter the linear strip of the second low-friction coating has beenapplied to the twisted medical guide wire. FIGS. 38B to 38D displaysubsequent points in time after the first end and/or the second end ofthe medical guide wire have been released and the medical guide wire isuntwisting to its original configuration. As seen in FIGS. 38B to 38D,the shape of the linear strip of the second low-friction coating of FIG.38A is gradually twisting as the medical guide wire untwists. FIG. 38Edisplays a subsequent point in time after the medical guide wire hasreturned to its original configuration, wherein the linear strip of thesecond low-friction coating of FIG. 38A has formed a spiral shapedstrip.

In an alternative embodiment, rather than coating the medical guide wirewith a first low-friction coating, a precoated medical guide wire isutilized. In one such embodiment, a medical guide wire which includes aprecoated and partially cured first low-friction coating is utilized toform one or more spiral shaped strips as disclosed herein. In anothersuch embodiment, a medical guide wire which includes a precoated andfully cured first low-friction coating is utilized to form one or morespiral shaped strips as disclosed herein. Such embodiments bypasses thestep of applying the first low-friction coating and begins the processesdescribed herein with a precoated medical guide wire. In one suchembodiment, the continuous length of a wire is coated, reel to reel,with a first low-friction coating and then this coated wire is formed ina medical guide wire that is fully coated with this first low-frictioncoating. In different embodiments, this first coating applied to theprecoated medical guide wire is a Xylan 1514 low-friction coating withthe appropriate pigments, a VICOTE™ 700 Series coating with theappropriate pigments, a VICOTE™ 800 Series coating with the appropriatepigments, a DuPont™ 420 Series coating with the appropriate pigments, aDuPont™ 851-504 coating with the appropriate pigments, a DuPont™ 851N204coating with the appropriate pigments, a DuPont™ 851N504 coating withthe appropriate pigments, a DuPont™ 851N604 coating with the appropriatepigments, a WHITFORD OC 600 Series coating with the appropriatepigments, a WHITFORD OC 625 Series coating with the appropriatepigments, a WHITFORD OC 655 Series coating with the appropriatepigments, a WHITFORD OC 8800 Series coating with the appropriatepigments, a MANSFIELD PROTECTIVE PRODUCTS MPC 992003 coating with theappropriate pigments, a Ultralon® OC Series coating with the appropriatepigments, or a Fluoroplate® 41141 Series coating manufactured by OrionIndustries, Ltd., with the appropriate pigments or any suitable coating.

It should be appreciated that regardless of if the method describedherein applies the first low-friction coating or utilizes a medicalguide wire that has been precoated with a first low-friction coating,the second low-friction coating is selectively applied to and bonds withsuch first low-friction coatings in the formation of the spiral shapedmedical guide wire described herein. It should be further appreciatedthat any of the coated medical devices or partially coated medicaldevices described herein may be utilized as a medical device with afirst low-friction coating previously applied.

In one embodiment, any of the above-described methods of manufacturing amedical guide wire may be fully or partially manually performed Inanother embodiment, any of the above-described methods of manufacturinga medical guide wire may be fully or partially automated for precision.That is, one or more of the steps of applying a first low-frictioncoating, curing the applied first low-friction coating, securing a firstend of the medical guide wire, twisting or turning a second end of themedical guide wire a designated quantity of times, securing the secondend of the medical guide wire, blocking one or more parts of the twistedmedical guide wire, applying a second contrasting colored low-frictioncoating to at least a second portion of the outer surface of the medicalguide wire and/or releasing the first end and the second end of themedical guide wire may be fully or partially automated.

It should be appreciated that any of the above-described methods ofmanufacturing a medical guide wire may be simultaneously performed for aplurality of medical guide wires. That is, one or more of the steps ofapplying a first low-friction coating, curing the applied firstlow-friction coating, securing a first end of the medical guide wire,twisting or turning a second end of the medical guide wire a designatedquantity of times, securing the second end of the medical guide wire,blocking one or more parts of the twisted medical guide wire, applying asecond contrasting colored low-friction coating to at least a secondportion of the outer surface of the medical guide wire and/or releasingthe first end and the second end of the medical guide wire may besimultaneously or substantially simultaneously performed for a pluralityof medical guide wires. For example, a group of ten or more medicalguide wires are laid side-by-side adjacent to each other along amagnetic table. In this embodiment, such medical guide wires have onlytwo masking sides as the magnetic table holds the medical guide wiresflat. This example proceeds as described above wherein the secondcoating is applied as a stripe the width of the medical guide wire(i.e., between 0.016 to 0.038 inches which is fixed by the diameter ofthe wire).

In another embodiment, a plurality of contrasting colored low-frictioncoatings are applied to different portions of the twisted medical guidewire to form a plurality of different colored spiral shaped patterns.For example, a second, different colored low-friction coating is appliedto a first longitudinal portion of the twisted medical guide wire and athird, different colored low-friction coating is applied to a secondlongitudinal portion of the twisted medical guide wire. In this example,when the medical guide wire is untwisted, the medical guide wire willinclude a first spiral shaped pattern of the second low-friction coatingand a second, different colored, same spiral shaped pattern of the thirdlow-friction coating. It should be appreciated that in this example,since both the second and third low-friction coatings are applied to thesame twisted medical guide wire (without any loosening or tightening ofthe medical guide wire between applications of these two low-frictioncoatings), the distances between the centers of adjacent spiral marksfor both formed spiral shaped patterns will be the same.

In another embodiment, a plurality of different shaped spiral patternsare formed along the length of the medical guide wire. In one suchembodiment, a second, different colored low-friction coating is appliedalong a first portion of a twisted medical guide wire (as describedabove) and the medical guide wire is then twisted more and a third,contrasting colored low-friction coating is then applied along a secondportion of this further twisted medical guide wire. In another suchembodiment, a second, different colored low-friction coating is appliedalong a first portion of a twisted medical guide wire (as describedabove) and the medical guide wire is then loosened and a third,contrasting colored low-friction coating is then applied along a secondportion of this further twisted medical guide wire. These embodimentsprovide a medical guide wire with a plurality of different colored anddifferent spiral shaped patterns. That is, when the medical guide wireis untwisted, the medical guide wire will include a first spiral shapedpattern of the second low-friction coating and a second, differentcolored and different spiral shaped pattern of the third low-frictioncoating. It should be appreciated that in these embodiments, since thethird low-friction coating is applied to the medical guide wire afterloosening or further tightening of the medical guide wire from when thesecond low-friction coating was applied, the distances between thecenters of adjacent spiral marks for both formed spiral shaped patternswill be different.

In another embodiment, rather than securing the first end of the medicalguide wire and twisting the medical guide wire such that the formedspiral shaped pattern begins at the first end of the medical guide wireas described above, any suitable portion of the medical guide wire issecured. In this embodiment, the formed spiral shaped pattern will beginat the portion of the medical guide wire that is secured. In one exampleembodiment, if the medical guide wire is secured at a halfway portion ofthe medical guide wire, then after one of the ends of the medical guidewire is twisted and the second coating is selectively applied to thattwisted half of the medical guide wire, half the length of the untwistedmedical guide wire will have a spiral shaped pattern and the other halfof the untwisted medical guide wire will not have a spiral shapedpattern. In one such embodiment, the other half of the untwisted medicalguide wire that does not include any spiral shaped patterns will includesuitable markings to indicate distance. This embodiment provides thatthe half of the medical guide wire that is inserted into the patientincludes one or more spiral shaped patterns (to enable the medicalprofessional to determine if the medical guide wire is moving in thepatient) and the other half of the medical guide wire that is notinserted into the patient includes suitable markings to indicatedistance (to enable the medical professional to determine the distancethe medical guide wire has traveled into the patient).

In another example embodiment, if the medical guide wire is secured at ahalfway portion of the medical guide wire, and the two ends of themedical guide wire are each twisted a different quantity of times, thenafter the second coating is selectively applied to two twisted halves ofthe medical guide wire, half the length of the untwisted medical guidewire will have a first spiral shaped pattern and the other half of theuntwisted medical guide wire will have a different spiral shapedpattern. In another example embodiment, different portions of themedical guide wire are secured and suitably twisted such that certainportions (e.g., one half) of the medical guide wire has a plurality ofdifferent spiral shaped patterns and other portions (e.g., the otherhalf) of the medical guide wire do not have any spiral shaped patterns.Such example embodiments provides a medical professional an easyidentifying marker for the different points of the medical guide wire.

In another embodiment, different portions of the medical guide wire aresuitably secured prior to twisting the medical guide wire and applyingthe second coating as described above. Such different secured portionsdo not include the formed spiral shaped pattern when the medical guidewire returns to its original configuration and thus such differentportions provide a suitable distance marking system. In other words, thebreaks of the spiral shaped pattern along the length of the medicalguide wire (that are caused by such secured portions) provide suitableindications of distance for the medical professional using the markedmedical guide wire disclosed herein. It should be appreciated that inaddition to providing a medical guide wire with a spiral shaped pattern,any of embodiments for marking distance or applying other suitableindicia disclosed herein may also be implemented in accordance with thisembodiment. In one such embodiment, a strip of the second low-frictioncoating is applied along the length of the medical guide wire eitherprior to or after the twisting of the medical guide wire to form thespiral shaped pattern described above. In another such embodiment, alongitudinal strip of the second low-friction coating is applied alongpart, but not the entire length of the medical guide wire (e.g., halfthe length of the medical guide wire) and the spiral shaped patterndescribed above is also applied along part, but not the entire length ofthe medical guide wire (e.g., the other half of the medical guide wire).

In another embodiment, the spiral shaped medical guide wire disclosedherein may also indicate any suitable indicia or markings disclosedherein. In such embodiments, either prior to twisting the medical guidewire and applying a second coating to a longitudinally extending portionof the twisted medical guide wire (to form a spiral shaped pattern onthe untwisted medical guide wire) or after twisting the medical guidewire and applying a second coating to a longitudinally extending portionof the twisted medical guide wire (to form a spiral shaped pattern onthe untwisted medical guide wire), one or more indicia or markings arecreated on the medical guide wire. In different embodiments, the medicalguide wire with one or more spiral shaped patterns also includes one ormore: portions coated with different colored first low-frictioncoatings, bands which indicate distance (as described above),longitudinal lines which indicate distance, parallel lines, bands orstripes, perpendicular lines, bands or stripes, transverse lines, bandsor stripes, axial lines, bands or stripes, longitudinal lines, bands orstripes, spiral patterned lines, bands or stripes, numbers, letters, barcodes, and/or marks which indicate the size, type, material, partnumber, serial number, lot number, manufacturing date, instructions foruse, manufacturer of the medical device, any indicia or markingdisclosed herein or any combination thereof. For example, laser energy,from a CO₂ laser, a fiber laser or a YAG laser, is utilized to ablate adistinctive character into each coil of the medical guide wire disclosedherein. In this example, since each character is indicated one theindividual outer diameter of each adjacent a separate coil of themedical guide wire (rather than each character spanning over a pluralityof coils or spanning across an entire coil and into the area between anadjacent coil), such characters are crisp and formed at a right angle tothe laser beam.

It should be appreciated that the twisting of the medical device andapplying a contrasting colored low-friction coating to form one or morespiral patterns may be utilized in any of the marked medical devicesdisclosed herein. It should be further appreciated that in addition totwisting the medical device and applying a second, contrasting coloredlow-friction coating to form one or more spiral patterns, in anotherembodiment, the spiral patterns are formed by twisting the medicaldevice and selectively heating different portions of the coated medicaldevice to cause a color shifting of one or more pigments included in thecoating previously applied to the medical device. In another embodiment,the spiral patterns are formed by applying two contrasting coloredcoatings to a medical device, twisting the medical device and thenapplying a laser along the length of the medical device to laser ablatethe first coating.

In another embodiment, a clear or transparent top coat is applied to oneor more of the surfaces of the coated medical device after the secondlow-friction coating has been selectively applied to the exposedsurfaces of the medical device. In one embodiment, the top coating is alow-friction or release coating or material, such as fluorinatedmaterials, polytetrafluoroethylene, perfluoro-alkoxy,fluoroethylenepropylene, MFA, polyethylene, silicone, a resin like clearmedical grade epoxy in liquid or power form, ceramic composites,paralyene silane polymers and other suitable low-friction coatings. Sucha top coating provides that the markings described above aresubstantially covered or sealed underneath an additional layer skin of alow friction coating.

In different embodiments, an additional hydrophilic top coat is appliedto one or more of the different coated medical devices disclosed herein.In one such embodiment, a hydrophilic top coat is applied over one ormore coatings which include one or more energy sensitive pigments. Inanother such embodiment, a hydrophilic top coat is applied over one ormore coatings which include one or more bands of radiopaque materials.In another such embodiment, a hydrophilic top coat is applied over oneor more medical devices which include at least one area of an outerlow-friction coating removed to reveal an inner low-friction coating ofa contrasting color. In these embodiments, a hydrophilic top coat isapplied to one or more areas or portions of such medical devices toprovide an additional low-friction coating. In one such embodiment, thehydrophilic top coat is applied to the previously applied low-frictioncoating and then suitably heat or UV cured to adhere the hydrophilic topcoat to the low-friction coating.

It should be understood that various changes and modifications to thepresently preferred embodiments described herein will be apparent tothose skilled in the art. Such changes and modifications can be madewithout departing from the spirit and scope of the present subjectmatter and without diminishing its intended advantages. It is thereforeintended that such changes and modifications be covered by the appendedclaims.

1. A coated medical guide wire comprising: a body formed by a helicallywound wire; a first coating applied to a first portion of an outersurface of the body, said first coating including: (i) a first pigmentof a first color, and (ii) a plurality of particles of a firstlow-friction material; and a second coating applied to a substantiallyspiral shaped portion of the first portion of the outer surface of thebody, said substantially spiral shaped portion extending in a directionaround a central longitudinal axis of the body and the second coatingincluding: (i) a second pigment of a second color, said second colorbeing of a contrasting hue of the first color, and (ii) a plurality ofparticles of a second low-friction material.
 2. The medical guide wireof claim 1, wherein the first low friction material and the second lowfriction material are a same low friction material.
 3. The medical guidewire of claim 1, which includes a third coating applied to a secondsubstantially spiral shaped portion of the first portion of the outersurface of the body, said second substantially spiral shaped portionextending in the direction of the central longitudinal axis of the bodyand the third coating including: (i) a third pigment of a third color,said third color being of a contrasting hue of the first color and thesecond color, and (ii) a plurality of particles of a low-frictionmaterial.
 4. The medical guide wire of claim 3, wherein the firstsubstantially spiral shaped portion and the second substantially spiralshaped portion are spaced apart from each other.
 5. The medical guidewire of claim 1, wherein a length of the first portion of the outersurface of the body is substantially equal to a length of thesubstantially spiral shaped portion.
 6. The medical guide wire of claim5, which includes at least one non-spiral marking that indicates atleast one selected from the group consisting of: a distance, a number, aletter, a bar code, a size of the medical guide wire, a type of themedical guide wire, a material of the medical guide wire, a part numberof the medical guide wire, a serial number of the medical guide wire, alot number of the medical guide wire, a manufacturing date of themedical guide wire, a plurality of instructions for use of the medicalguide wire, and a manufacturer of the medical guide wire.
 7. The medicalguide wire of claim 1, which includes at least one non-spiral markingthat indicates at least one selected from the group consisting of: adistance, a number, a letter, a bar code, a size of the medical guidewire, a type of the medical guide wire, a material of the medical guidewire, a part number of the medical guide wire, a serial number of themedical guide wire, a lot number of the medical guide wire, amanufacturing date of the medical guide wire, a plurality ofinstructions for use of the medical guide wire, and a manufacturer ofthe medical guide wire.
 8. The medical guide wire of claim 1, wherein atleast one of the first coating and the second coating includes aplurality of radiopaque particles.
 9. The medical guide wire of claim 1,wherein at least one of the first coating and the second coatingincludes a plurality of interspersed anti-microbial particles.
 10. Themedical guide wire of claim 9, wherein the anti-microbial particles areselected from the group consisting of: silver particles, glass-silverparticles, silver-ceramic particles, and ceramic particles.
 11. Themedical guide wire of claim 1, which includes an additional top coatingincluding a plurality of particles of a low-friction material.
 12. Themedical guide wire of claim 1, wherein the first pigment is selectedfrom a group consisting of: a phthalocyanine blue, a phthalocyaninegreen, a diarylide yellow, a diarylide orange, a quanacridone, anaphthol, a toluidine red, a carbizole violet, a carbon black, an ironoxide red, an iron oxide yellow, a chrome oxide green, a titanium oxidewhite, a cadmium red, a ultramarine blue, a moly orange, a lead chromateyellow, a mixed metal oxide, a talc, a calcium carbonate, a silicate andsulfate, a silica, a mica, an aluminum hydrate and silicate, a bariumsulfate, a pearl pigment, a kaolin, an aluminum silicate derivative, anantomony trioxide, a metallic pigment, an aluminum flake pigment, and aniron oxide.
 13. The medical guide wire of claim 1, wherein the secondpigment is selected from a group consisting of: a phthalocyanine blue, aphthalocyanine green, a diarylide yellow, a diarylide orange, aquanacridone, a naphthol, a toluidine red, a carbizole violet, a carbonblack, an iron oxide red, an iron oxide yellow, a chrome oxide green, atitanium oxide white, a cadmium red, a ultramarine blue, a moly orange,a lead chromate yellow, a mixed metal oxide, a talc, a calciumcarbonate, a silicate and sulfate, a silica, a mica, an aluminum hydrateand silicate, a barium sulfate, a pearl pigment, a kaolin, an aluminumsilicate derivative, an antomony trioxide, a metallic pigment, analuminum flake pigment, and an iron oxide.
 14. A coated medical devicecomprising: a body; a first coating applied to a first portion of anouter surface of the body, said first coating including: (i) a firstpigment of a first color, and (ii) a plurality of particles of a firstlow-friction material; a second coating applied to a substantiallyspiral shaped portion of the first portion of the outer surface of thebody, said substantially spiral shaped portion extending in a directionaround a central longitudinal axis of the body, a length of the firstportion of the outer surface of the body being substantially equal to alength of the substantially spiral shaped portion and the second coatingincluding: (i) a second pigment of a second color, said second colorbeing of a contrasting hue of the first color, and (ii) a plurality ofparticles of a second low-friction material; and at least one non-spiralmarking of one of: the first color and a third color of a contrastinghue of the first color and the second color, said at least onenon-spiral marking indicating at least one selected from the groupconsisting of: a distance, a number, a letter, a bar code, a size of themedical device, a type of the medical device, a material of the medicaldevice, a part number of the medical device, a serial number of themedical device, a lot number of the medical device, a manufacturing dateof the medical device, a plurality of instructions for use of themedical device, and a manufacturer of the medical device.
 15. Themedical device of claim 14, wherein the first low friction material andthe second low friction material are a same low friction material. 16.The medical device of claim 14, wherein at least one of the firstcoating and the second coating includes a plurality of radiopaqueparticles.
 17. The medical device of claim 14, wherein at least one ofthe first coating and the second coating includes a plurality ofinterspersed anti-microbial particles.
 18. The medical device of claim17, wherein the anti-microbial particles are selected from the groupconsisting of: silver particles, glass-silver particles, silver-ceramicparticles, and ceramic particles.
 19. The medical device of claim 14,which includes an additional top coating including a plurality ofparticles of a low-friction material.
 20. The medical device of claim14, wherein the first pigment is selected from a group consisting of: aphthalocyanine blue, a phthalocyanine green, a diarylide yellow, adiarylide orange, a quanacridone, a naphthol, a toluidine red, acarbizole violet, a carbon black, an iron oxide red, an iron oxideyellow, a chrome oxide green, a titanium oxide white, a cadmium red, aultramarine blue, a moly orange, a lead chromate yellow, a mixed metaloxide, a talc, a calcium carbonate, a silicate and sulfate, a silica, amica, an aluminum hydrate and silicate, a barium sulfate, a pearlpigment, a kaolin, an aluminum silicate derivative, an antomonytrioxide, a metallic pigment, an aluminum flake pigment, and an ironoxide.
 21. The medical device of claim 14, wherein the second pigment isselected from a group consisting of: a phthalocyanine blue, aphthalocyanine green, a diarylide yellow, a diarylide orange, aquanacridone, a naphthol, a toluidine red, a carbizole violet, a carbonblack, an iron oxide red, an iron oxide yellow, a chrome oxide green, atitanium oxide white, a cadmium red, a ultramarine blue, a moly orange,a lead chromate yellow, a mixed metal oxide, a talc, a calciumcarbonate, a silicate and sulfate, a silica, a mica, an aluminum hydrateand silicate, a barium sulfate, a pearl pigment, a kaolin, an aluminumsilicate derivative, an antomony trioxide, a metallic pigment, analuminum flake pigment, and an iron oxide.